ACETAMINOPHEN ORAL SOLUTION solution DIPHENHYDRAMINE HYDROCHLORIDE liquid MILK OF MAGNESIA- magnesium hydroxide suspension

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)
Available from:
Major Pharmaceuticals
Administration route:
ORAL
Prescription type:
OTC DRUG
Authorization status:
OTC monograph not final
Authorization number:
0904-6738-70, 0904-6739-71, 0904-6740-70, 0904-6741-72, 0904-6820-76, 0904-6840-72, 0904-6846-73

ACETAMINOPHEN ORAL SOLUTION- acetaminophen oral solution solution

DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride liquid

MILK OF MAGNESIA- magnesium hydroxide suspension

Major Pharmaceuticals

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Major Pharmaceuticals

Unit dose OTC Monograph drugs

Diphenhydramine HCl, APAP and Milk of Mag (conc and non-conc)

Acetaminophen Oral Solution 160 mg/ 5 mL Unit Dose Cup

Major Pharmaceutical

NDC 0904-6738-70

Acetaminophen

Oral Solution, USP

160 mg / 5 mL

Delivers 5 mL

See Insert

For Institutional Use Only

MAJOR PHARMACEUTICALS

Livonia, MI 48152

Sugar Free - Dye Free - Alcohol Free

Acetaminophen 160 mg / 5 mL Unit Dose Cup

Major Pharmaceuticals

Directions

Do not use more than directed Shake well before use

Age (yr)

Dose (mL)

adults

take 20 mL (640 mg) every 4 to 6

hours

not to exceed 6 doses in a 24-

hour period

do not use more than 10 days

unless directed by a doctor

under 18

years of age

ask a doctor

Acetaminophen 160 mg / 5 mL

Major Pharmaceuticals

Keep out of reach of children.

Overdose warning: taking more than the recommended dose (overdose) may cause liver damage. In

case of overdose, get medical help or contact Poison Control Center (1-800-222-1222) right away.

Quick medical attention is critical for adults as well as for children even if you do not notice any signs

or symptoms.

Acetaminophen 160 mg / 5 mL

Major Pharmaceuticals

Do not use

- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure

whether a drug contains acetaminophen, ask a doctor or pharmacist.

- if you are allergic to acetaminophen or any other inactive ingredients in this product

____________________________________________________________________________

Ask a doctor before use if the user

- has liver disease - is pregnant or breast-feeding

____________________________________________________________________________

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

____________________________________________________________________________

Stop use and ask a doctor if

- pain gets worse or lasts more than 10 days - new symptoms occur

- fever gets worse or lasts more than 3 days - redness or swelling is present

These could be signs of a serious condition

Acetaminophen 160 mg / 5 mL

Major Pharmaceuticals

Inactive ingredients cherry flavor, citric acid, glycerin, methylcellulose, microcrystalline cellulose,

propyl paraben, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xantham gum

Acetaminophen 160 mg / 5 mL

Major Pharmaceuticals

Uses temporarily relieves minor aches and pains due to:

minor pain of arthritis

muscular aches

backache

premenstrual and menstrual cramps

the common cold

headache

toothache

temporarily reduces fever

Acetaminophen 160 mg / 5 mL

Major Pharmaceuticals

Active ingredient (in each 5 mL cup) Purpose Acetaminophen USP 160 mg…………………………..

………………..Pain reliever / fever reducer

Acetaminophen 160 mg / 5 mL

Major Pharmaceuticals

Pain reliever / fever reducer

Acetaminophen 160 mg / 5 mL

Major Pharmaceuticals

Other information

- store at 20°-25°C (68°-77°F). Avoid excessive heat 40°C (104°F)

- protect from excessive moisture - do not use if lid seal is open or damaged

- sugar free, dye free, alcohol free - see bottom of cup for lot number and expiration date

Acetaminophen 160 mg / 5 mL

Major Pharmaceuticals

Diphenhydramine HCl 12.5 mg/ 5 mL Cups

NDC 0904-6740-70

Diphenhydramine HCl

Oral Solution, USP

12.5 mg/5 mL

Antihistamine - Delivers 5 mL

See Insert

For Instituional Use Only

MAJOR PHARMACEUTICALS

Livonia, MI 64152

Sugar Free - Dye Free - Alcohol Free

Diphenhydramine HCl 12.5 mg/5 mL

Major Pharmaceuticals - Institutional Use Only

Directions

Use the following dosage guidelines when using this product

Age (yr)

Dose (mL)

adults and children 12 years and over

take 10 mL every 4 to 6 hours; not more than 60 mL in 24 hours

children 6 years to under 12 years

take 5 mL every 4 to 6 hours; not more than 30 mL in 24 hours

children under 6 years

ask a doctor

Diphenhydramine HCl 12.5 mg/5 mL

Major Pharmaceuticals - For Institutional Use Only

Warnings

Do not use

in neonates or premature infants

if pregnant or breast-feeding

if hypersensitive to diphenhydramine HCl and other similar antihistamines

with any other product containing diphenhydramine, even one used on skin

to make a child sleepy

___________________________________________________________________

Ask a doctor before use if you have

glaucoma a breathing problem such as emphysema or chronic bronchitis

a sodium restricted diet trouble urinating due to an enlarged prostate gland

___________________________________________________________________

Ask a doctor or pharmacist before use if

taking tranquilizers or sedatives

___________________________________________________________________

When using this product

marked drowsiness may occur avoid alcoholic drinks

alcohol, sedatives, and tranquilizers may increase drowsiness

be careful when driving a motor vehicle or operating machinery

excitability may occur, especially in children

___________________________________________________________________

Diphenhydramine HCl 12.5 mg/5 mL

Major Pharmaceuticals - for Institutional Use Only

Inactive ingredients cherry flavor, citric acid, glycerin, monoammonium glycyrrhizinate, poloxamer

407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucralose

Diphenhydramine HCl 12.5 mg/5 mL

Major Pharmaceuticals - For Institutional Use Only

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny

nose sneezing itchy, watery eyes itchy throat

Diphenydramine HCl 12.5 mg/ 5 mL

Major Pharmaceutical - For Institutional Use Only

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Diphenhydramine HCl 12.5 mg/ 5 mL

Major Pharmaceuticals - For Intitutional Use Only

Antihistamine

Diphenhydramine HCl 12.5 mg/ 5 mL

Major Pharmaceuticals - For Institutional Use Only

Major Pharmaceuticals - For Institutional Use Only

Active ingredient (in each 5 mL cup) Purpose Diphenhydramine HCl USP 12.5 mg..

………………………………………Antihistamine

Diphenhydramine HCl 12.5 mg/5 mL

Major Pharmaceuticals - For Institutional Use Only

Other information

each 5 mL contains: sodium 15 mg

store at 20-25°C (68-77°F)

protect from excessive moisture

do not use if lid seal is open or damaged

sugar free, dye free, alcohol free

see bottom of cup for lot number and expiration date

Diphenhydramine HCl 12.5 mg/ 5 mL

Major Pharmaceuticals - IFU - For Institutional use Only

Product Insert

Diphenhydramine HCl Oral Solution, USP

NDC 0904-6740-70

10 x 5 mL Unit Dose Cups

Active ingredient (in each 5 mL cup) Purpose Diphenhydramine HCl USP 12.5 mg..

………………………………………Antihistamine

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose

sneezing

itchy, watery eyes

itchy throat

Warnings

Do not use

in neonates or premature infants

if pregnant or breast-feeding

if hypersensitive to diphenhydramine HCl and other similar antihistamines

with any other product containing diphenhydramine, even one used on skin

to make a child sleepy

Ask a doctor before use if you have

glaucoma

a breathing problem such as emphysema or chronic bronchitis

a sodium restricted diet

trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if

taking tranquilizers or sedatives

When using this product

marked drowsiness may occur

avoid alcoholic drinks

alcohol, sedatives, and tranquilizers may increase drowsiness

be careful when driving a motor vehicle or operating machinery

excitability may occur, especially in children

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Other information

each 5 mL contains: sodium 15 mg

store at 20-25°C (68-77°F)

protect from excessive moisture

do not use if lid seal is open or damaged

sugar free, dye free, alcohol free

see bottom of cup for lot number and expiration date

Inactive ingredients cherry flavor, citric acid, glycerin, monoammonium glycyrrhizinate, poloxamer

407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucralose

Directions

Use the following dosage guidelines when using this product

Age (yr) Dose (mL)

adults and children 12 years and over take 10 mL every 4 to 6 hours; not more than 60 mL in 24 hours

children 6 years to under 12 years take 5 mL every 4 to 6 hours; not more than 30 mL in 24 hours

children under 6 years ask a doctor

Questions or comments?

Call 1-800-616-2471

Re-order No. 700900

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Dr., Suite 233

Livonia, MI 48152

Diphenhydramine HCl 25 mg / 10 mL Cups

NDC 0904-6741-72

Diphenhydramine HCl

Oral Solution, USP

25 mg/10 mL

Antihistamine - Delivers 10 mL

See Insert

For Instituional Use Only

MAJOR PHARMACEUTICALS

Livonia, MI 64152

Sugar Free - Dye Free - Alcohol Free

Diphenhydramine HCl 25 mg/ 10 mL

Major Pharmaceuticals - for Instutional use Only

Directions

Use the following dosage guidelines when using this product

Age (yr) Dose (mL)

adults and children 12 years and over take 10 mL every 4 to 6 hours; not more than 60 mL in 24 hours

children 6 years to under 12 years ask a doctor

Diphenhydramine HCl 10 mg/ 10 mL

Major Pharmaceuticals - For Institutional Use Only

Warnings

Do not use

in neonates or premature infants

if pregnant or breast-feeding

if hypersensitive to diphenhydramine HCl and other similar antihistamines

with any other product containing diphenhydramine, even one used on skin

to make a child sleepy

___________________________________________________________________

Ask a doctor before use if you have

glaucoma a breathing problem such as emphysema or chronic bronchitis

a sodium restricted diet trouble urinating due to an enlarged prostate gland

___________________________________________________________________

Ask a doctor or pharmacist before use if

taking tranquilizers or sedatives

___________________________________________________________________

When using this product

marked drowsiness may occur avoid alcoholic drinks

alcohol, sedatives, and tranquilizers may increase drowsiness

be careful when driving a motor vehicle or operating machinery

excitability may occur, especially in children

Diphenhydramine HCl 25 mg/ 10 mL

Major Pharmaceuticals - For Institutional Use Only

Inactive ingredients cherry flavor, citric acid, glycerin, monoammonium glycyrrhizinate, poloxamer

407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucralose

Diphenhydramine HCl 10 mg / 10 mL

Major Pharmaceuticals - For Institutional Use Only

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny

nose sneezing itchy, watery eyes itchy throat

Diphenhydramine HCl 25 mg/ 10 mL

Major Pharmaceuticals - For Institutional use Only

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Diphenhydramine HCl 25 mg/ 10 mL

Major Pharmaceuticals - For Institutional Use Only

Antihistamine

Diphenhydramine HCl 25 mg/ 10 mL

Major Pharmaceuticals - For Institutional Use Only

Active ingredient (in each 10 mL cup) Purpose Diphenhydramine HCl USP 25 mg..

………………………………………Antihistamine

Diphenhydramine HCl 25 mg/ 10 mL

Major Pharmaceuticals - For Institutional Use Only

each 10 mL contains: sodium 30 mg

store at 20-25°C (68-77°F)

protect from excessive moisture

do not use if lid seal is open or damaged

sugar free, dye free, alcohol free

see bottom of cup for lot number and expiration date

Diphenhydramine HCl 25 mg/ 10 mL

Major Pharmaceuticals - IFU - For Institutional Use Only

roduct Insert

Diphenhydramine HCl Oral Solution, USP

NDC 0904-6741-72

10 x 10 mL Unit Dose Cups

Active ingredient (in each 10 mL cup) Purpose Diphenhydramine HCl USP 25 mg..

………………………………………Antihistamine

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose

sneezing

itchy, watery eyes

itchy throat

Warnings

Do not use

in neonates or premature infants

if pregnant or breast-feeding

if hypersensitive to diphenhydramine HCl and other similar antihistamines

with any other product containing diphenhydramine, even one used on skin

to make a child sleepy

Ask a doctor before use if you have

glaucoma

a breathing problem such as emphysema or chronic bronchitis

a sodium restricted diet

trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if

taking tranquilizers or sedatives

When using this product

marked drowsiness may occur

avoid alcoholic drinks

alcohol, sedatives, and tranquilizers may increase drowsiness

be careful when driving a motor vehicle or operating machinery

excitability may occur, especially in children

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

Use the following dosage guidelines when using this product

Age (yr) Dose (mL)

adults and children 12 years and over take 10 mL every 4 to 6 hours; not more than 60 mL in 24 hours

children 6 years to under 12 years ask a doctor

Other information

each 10 mL contains: sodium 30 mg

store at 20-25°C (68-77°F)

protect from excessive moisture

do not use if lid seal is open or damaged

sugar free, dye free, alcohol free

see bottom of cup for lot number and expiration date

Inactive ingredients cherry flavor, citric acid, glycerin, monoammonium glycyrrhizinate, poloxamer

407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucralose

Questions or comments?

Call 1-800-616-2471

Re-order

No. 700901

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Dr., Suite 233

Livonia, MI 48152

Acetaminophen 325 mg / 10.15 mL

Major Pharmaceuticals

NDC 0904-6739-71

Acetaminophen

Oral Solution, USP

325 mg / 10.15 mL

Delivers 10.15 mL

See Insert

For Institutional Use Only

MAJOR PHARMACEUTICALS

Livonia, MI 48152

Sugar Free - Dye Free - Alcohol Free

Acetaminophen 325 mg / 10.15 mL

Major Pharmaceuticals

Directions

Do not use more than directed Shake well before use

Age (yr)

Dose (mL)

adults

take 20.3 mL (650 mg) every 4 to 6

hours

not to exceed 6 doses in a 24-hour

period

do not use more than 10 days unless

directed by a doctor

under 18

years of age

ask a doctor

Acetaminophen 325 mg / 5 mL

Major Pharmaceuticals

Do not use

- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure

whether a drug contains acetaminophen, ask a doctor or pharmacist.

- if you are allergic to acetaminophen or any other inactive ingredients in this product

____________________________________________________________________________

Ask a doctor before use if the user

- has liver disease - is pregnant or breast-feeding

____________________________________________________________________________

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

____________________________________________________________________________

Stop use and ask a doctor if

- pain gets worse or lasts more than 10 days - new symptoms occur

- fever gets worse or lasts more than 3 days - redness or swelling is present

These could be signs of a serious condition

____________________________________________________________________________

Acetaminophen 325 mg / 10.15 mL

Major Pharmaceuticals

Inactive ingredients cherry flavor, citric acid, glycerin, methylcellulose, microcrystalline cellulose,

propyl paraben, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xantham gum

Acetaminophen 325 mg / 10.15 mL

Major Pharmaceuticals

Active ingredient (in each 10.15 mL cup) Purpose Acetaminophen USP 325 mg…………………………..

………………..Pain reliever / fever reducer

Acetaminophen 325 mg / 10.15 mL

Major Pharmaceuticals

Uses temporarily relieves minor aches and pains due to:

minor pain of arthritis

muscular aches

backache

premenstrual and menstrual cramps

the common cold

headache

toothache

temporarily reduces fever

Acetaminophen 325 mg / 10.15 mL

Major Pharmaceuticals

Keep out of reach of children.

Overdose warning: taking more than the recommended dose (overdose) may cause liver damage. In case

of overdose, get medical help or contact Poison Control Center (1-800-222-1222) right away. Quick

medical attention is critical for adults as well as for children even if you do not notice any signs or

symptoms.

Acetaminophen 325 mg / 10.15 mL

Major Pharmaceuticals

Pain reliever / fever reducer

Acetaminophen 325 mg / 10.15 mL

Major Pharmaceuticals

Other information

store at 20°-25°C (68°-77°F). Avoid excessive heat 40°C (104°F)

protect from excessive moisture

do not use if lid seal is open or damaged

sugar free, dye free, alcohol free

see bottom of cup for lot number and expiration date

Acetaminophen 325 mg / 10.15 mL

Major Pharmaceutcals - IFU

Acetaminophen 650 mg / 20.3 mL

Major Pharmaceuticals

NDC 0904-6820-76

Acetaminophen

Oral Solution, USP

650 mg / 20.3 mL

Delivers 20.3 mL

See Insert

For Institutional Use Only

MAJOR PHARMACEUTICALS

Livonia, MI 48152

Sugar Free - Dye Free - Alcohol Free

Acetaminophen 650 mg / 20.3 mL

Major Pharmaceuticals

Directions

Do not use more than directed Shake well before use

Age (yr)

Dose (mL)

adults

take 20.3 mL (650 mg) every 4 to 6

hours

not to exceed 6 doses in a 24-hour

period

do not use more than 10 days unless

directed by a doctor

under 18

years of age

ask a doctor

Acetaminophen 650 mg / 20.3 mL

Major Pharmaceuticals

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if

adults take more than 6 doses in 24 hours which is the maximum daily amount

taken with other drugs containing acetaminophen

adult has 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening

blisters

rash

If a skin reaction occurs, stop use and seek medical help right away

____________________________________________________________________________

Do not use

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure

whether a drug contains acetaminophen, ask a doctor or pharmacist.

if you are allergic to acetaminophen or any other inactive ingredients in this product

____________________________________________________________________________

Ask a doctor before use if the user

has liver disease

is pregnant or breast-feeding

____________________________________________________________________________

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

____________________________________________________________________________

Stop use and ask a doctor if

pain gets worse or lasts more than 10 days

new symptoms occur

fever gets worse or lasts more than 3 days

redness or swelling is present

These could be signs of a serious condition

Acetaminophen 650 mg / 20.3 mL

Major Pharmaceuticals

Inactive ingredients cherry flavor, citric acid, glycerin, methylcellulose, microcrystalline cellulose,

propyl paraben, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xantham gum

Acetaminophen 650 mg / 20.3 mL

Major Pharmaceuticals

Uses temporarily relieves minor aches and pains due to:

minor pain of arthritis

muscular aches

backache

premenstrual and menstrual cramps

the common cold

headache

toothache

temporarily reduces fever

Acetaminophen 650 mg / 20.3 mL

Major Pharmaceuticals

Keep out of reach of children.

Overdose warning: taking more than the recommended dose (overdose) may cause liver damage. In case

of overdose, get medical help or contact Poison Control Center (1-800-222-1222) right away. Quick

medical attention is critical for adults as well as for children even if you do not notice any signs or

symptoms.

Acetaminophen 650 mg / 20.3 mL

Major Pharmaceuticals - IFU

Acetaminophen 650 mg / 20.3 mL

Major Pharmaceuticals

Pain reliever / fever reducer

Acetaminophen 650 mg / 20.3 mL

Major Pharmaceuticals

Active ingredient (in each 20.3 mL cup) Purpose Acetaminophen USP 650 mg…………………………..

…….………..Pain reliever / fever reducer

Acetaminophen 650 mg / 20.3 mL

Major Pharmaceuticals

Other information

store at 20°-25°C (68°-77°F). Avoid excessive heat 40°C (104°F)

protect from excessive moisture

do not use if lid seal is open or damaged

sugar free, dye free, alcohol free

see bottom of cup for lot number and expiration date

Milk of Magnesia Concentrated 10 mL

Major Pharmaceutical OTC Monograph

NDC 0904-6840-72

Milk of Magnesia Concentrate

2400 mg/10 mL

Magnesium Hydroxide 2400 mg.

Saline Laxative

Shake Well

See Insert

For Instituional Use Only

MAJOR PHARMACEUTICALS

Livonia, MI 64152

Sugar Free - Dye Free - Alcohol Free

Milk of Magnesia Concentrated 2400 mg/ 10 mL

Directions

- do not exceed the maximum recommended daily dose in a 24 hour period

- shake well before use

- dose may be taken once a day preferably at bedtime, in divided doses, or as directed by a doctor

- drink a full glass (8 oz) of liquid with each dose

Age (yr)

Dose (mL)

adults and children

12 years and over

10 mL, not more than

20 mL in 24 hours

children under 12

years

ask a doctor

Milk of Magnesia Concentrated 2400 mg / 10 mL

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center

right away. (1-800-222-1222)

Milk of Magnesia concentrated 2400 mg / 10 mL

Warnings

Ask a doctor before use if you have

- kidney disease

- a magnesium-restricted diet

- stomach pain, nausea, or vomiting

- a sudden change in bowel habits that lasts more than 2 weeks

___________________________________________________________________

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more

hours before or after other drugs. Laxatives may affect how other drugs work.

___________________________________________________________________

Stop use and ask a doctor if

- you have rectal bleeding or no bowel movements after using this product. These could be signs of a

serious condition.

- you need to use a laxative for more than 1 week

___________________________________________________________________

If pregnant or breast-feeding, ask a health professional before use.

Milk of Magnesia concentrated 2400 mg / 10 mL

Inactive ingredients citric acid, glycerin, microcrystalline cellulose, methyl cellulose, purified water,

saccharin sodium, sodium citrate, spearmint oil, xantham gum

Milk of Magnesia Concentrated 2400 mg / 10 mL

Uses

- relieves occasional constipation (irregularity)

- generally produces bowel movement in ½ to 6 hours

Milk of Magnesia Concentrated 2400 mL / 10 mL

Active ingredient (in each 10 mL cup) Magnesium hydroxide USP 2400 mg

Milk of Magnesia concentrated 2400 mg / 10 mL

Saline laxative

Milk of Magnesia Concentrated 2400 mg / 10 mL

Other information

- each 10 mL contains: calcium 40 mg, sodium 35 mg, and magnesium 1000 mg

- store at 20-25°C (68-77°F)

- protect from excessive moisture

- do not use if lid seal is open or damaged

- sugar free, dye free, alcohol free

- see bottom of cup for lot number and expiration date

Milk of Magnesia Concentrated 2400 mg / 10 mL

Milk of Magnesia 2400 mg/30 mL

Major Pharmaceutical OTC Monograph

NDC 0904-6846-73

Milk of Magnesia USP

2400 mg/30 mL

Magnesium Hydroxide 2400 mg.

Saline Laxative

Shake Well

See Insert

For Instituional Use Only

MAJOR PHARMACEUTICALS

Livonia, MI 64152

Sugar Free - Dye Free - Alcohol Free

Milk of Magnesia 2400 mg/30 mL

Directions

- do not exceed the maximum recommended daily dose in a 24 hour period

- shake well before use

- dose may be taken once a day preferably at bedtime, or as directed by a doctor

- drink a full glass (8 oz) of liquid with each dose

Age (yr)

Dose (mL)

adults and children 12

years and over

30 mL, not more than

60 mL in 24 hrs.

children under 12

years

ask a doctor

Milk of Magnesia 2400 mg/ 30 mL

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center

right away. (1-800-222-1222)

Milk of Magnesia 2400 mg/ 30 mL

Warnings

Ask a doctor before use if you have

- kidney disease

- a magnesium-restricted diet

- stomach pain, nausea, or vomiting

- a sudden change in bowel habits that lasts more than 2 weeks

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or

more hours before or after other drugs. Laxatives may affect how other drugs work.

___________________________________________________________________

Stop use and ask a doctor if

- you have rectal bleeding or no bowel movements after using this product. These could be signs of a

serious condition.

- you need to use a laxative for more than 1 week

___________________________________________________________________

If pregnant or breast-feeding, ask a health professional before use.

Milk of Magnesia 2400 mg / 30 mL

Inactive ingredients citric acid, glycerin, microcrystalline cellulose, methyl cellulose, purified water,

saccharin sodium, sodium citrate, spearmint oil, xanthan gum

Milk of Magnesia 2400 mg / 30 mL

Uses

- relieves occasional constipation (irregularity)

- generally produces bowel movement in ½ to 6 hours

Milk of Magnesia 2400 mg / 30 mL

Active ingredient (in each 30 mL cup)

Magnesium hydroxide USP 2400 mg

Milk of Magnesia 2400 mg / 30 mL

Saline laxative

Milk of Magnesia 2400 mg / 30 mL

Other information

- each 30 mL contains: calcium 40 mg, sodium 100 mg, and magnesium 1000 mg

- store at 20-25°C (68-77°F) -

- protect from excessive moisture

- do not use if lid seal is open or damaged -

sugar free, dye free, alcohol free

- see bottom of cup for lot number and expiration date

Milk of Magnesia 2400 mg / 30 mL

ACETAMINOPHEN ORAL SOLUTION

acetaminophen oral solution solution

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 9 0 4-6 739

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

325 mg in 10 .15 mL

Inactive Ingredients

Ingredient Name

Stre ng th

GLYCERIN (UNII: PDC6 A3C0 OX)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

SO RBITO L (UNII: 50 6 T6 0 A25R)

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

METHYLCELLULO SE ( 15 CPS) (UNII: NPU9 M2E6 L8 )

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

XANTHAN GUM (UNII: TTV12P4NEE)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

Product Characteristics

Color

white (white to light pink)

S core

S hap e

S iz e

Flavor

CHERRY

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:0 9 0 4-6 739 -

10 in 1 CASE

0 4/0 8 /20 19

1

10 in 1 TRAY

1

10 .15 mL in 1 CUP, UNIT-DOSE; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt343

0 4/0 8 /20 19

DIPHENHYDRAMINE HYDROCHLORIDE

diphenhydramine hydrochloride liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 9 0 4-6 740

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DIPHENHYDRAMINE HYDRO CHLO RIDE (UNII: TC2D6 JAD40 ) (DIPHENHYDRAMINE

- UNII:8 GTS8 2S8 3M)

DIPHENHYDRAMINE

HYDROCHLORIDE

12.5 mg

in 5 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

AMMO NIUM GLYCYRRHIZATE (UNII: 3VRD35U26 C)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

TRISO DIUM CITRATE DIHYDRATE (UNII: B22547B9 5K)

PO LO XAMER 4 0 7 (UNII: TUF2IVW3M2)

GLYCERIN (UNII: PDC6 A3C0 OX)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

WATER (UNII: 0 59 QF0 KO0 R)

Product Characteristics

Color

S core

S hap e

S iz e

Flavor

CHERRY

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:0 9 0 4-6 740 -

10 in 1 CASE

12/0 4/20 18

1

10 in 1 TRAY

1

5 mL in 1 CUP, UNIT-DOSE; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

12/0 4/20 18

DIPHENHYDRAMINE HYDROCHLORIDE

diphenhydramine hydrochloride liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 9 0 4-6 741

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DIPHENHYDRAMINE HYDRO CHLO RIDE (UNII: TC2D6 JAD40 ) (DIPHENHYDRAMINE

- UNII:8 GTS8 2S8 3M)

DIPHENHYDRAMINE

HYDROCHLORIDE

25 mg

in 10 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

AMMO NIUM GLYCYRRHIZATE (UNII: 3VRD35U26 C)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

TRISO DIUM CITRATE DIHYDRATE (UNII: B22547B9 5K)

PO LO XAMER 4 0 7 (UNII: TUF2IVW3M2)

GLYCERIN (UNII: PDC6 A3C0 OX)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

WATER (UNII: 0 59 QF0 KO0 R)

Product Characteristics

Color

S core

S hap e

S iz e

Flavor

CHERRY

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:0 9 0 4-6 741-

10 in 1 CASE

12/0 4/20 18

1

10 in 1 TRAY

1

10 mL in 1 CUP, UNIT-DOSE; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

12/0 4/20 18

ACETAMINOPHEN ORAL SOLUTION

acetaminophen oral solution solution

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 9 0 4-6 738

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

16 0 mg in 5 mL

Inactive Ingredients

Ingredient Name

Stre ng th

GLYCERIN (UNII: PDC6 A3C0 OX)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

SO RBITO L (UNII: 50 6 T6 0 A25R)

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

METHYLCELLULO SE ( 15 CPS) (UNII: NPU9 M2E6 L8 )

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

XANTHAN GUM (UNII: TTV12P4NEE)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

Product Characteristics

Color

white (White to light pink)

S core

S hap e

S iz e

Flavor

CHERRY

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:0 9 0 4-6 738 -

10 in 1 CASE

0 4/0 8 /20 19

1

10 in 1 TRAY

1

5 mL in 1 CUP, UNIT-DOSE; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt343

0 4/0 8 /20 19

ACETAMINOPHEN ORAL SOLUTION

acetaminophen oral solution solution

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 9 0 4-6 8 20

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

6 50 mg in 20 .3 mL

Inactive Ingredients

Ingredient Name

Stre ng th

GLYCERIN (UNII: PDC6 A3C0 OX)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

SO RBITO L (UNII: 50 6 T6 0 A25R)

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

METHYLCELLULO SE ( 15 CPS) (UNII: NPU9 M2E6 L8 )

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

XANTHAN GUM (UNII: TTV12P4NEE)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

Product Characteristics

Color

white (white to light pink)

S core

S hap e

S iz e

Flavor

CHERRY

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:0 9 0 4-6 8 20 -

10 in 1 CASE

0 4/0 8 /20 19

1

10 in 1 TRAY

1

20 .3 mL in 1 CUP, UNIT-DOSE; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt343

0 4/0 8 /20 19

MILK OF MAGNESIA

magnesium hydroxide suspension

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 9 0 4-6 8 40

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of

Stre ng th

Stre ng th

MAGNESIUM HYDRO XIDE (UNII: NBZ3QY0 0 4S) (HYDROXIDE ION - UNII:9 159 UV38 1P,

MAGNESIUM CATION - UNII:T6 V3LHY8 38 )

MAGNESIUM

HYDROXIDE

240 0 mg

in 10 mL

Inactive Ingredients

Ingredient Name

Stre ng th

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

XANTHAN GUM (UNII: TTV12P4NEE)

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

METHYLCELLULO SE ( 15 CPS) (UNII: NPU9 M2E6 L8 )

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

TRISO DIUM CITRATE DIHYDRATE (UNII: B22547B9 5K)

GLYCERIN (UNII: PDC6 A3C0 OX)

WATER (UNII: 0 59 QF0 KO0 R)

Product Characteristics

Color

white (Suspensio n)

S core

S hap e

S iz e

Flavor

SPEARMINT

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:0 9 0 4-6 8 40 -

10 in 1 CASE

0 6 /10 /20 19

1

10 in 1 TRAY

1

10 mL in 1 CUP, UNIT-DOSE; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt331

0 6 /10 /20 19

MILK OF MAGNESIA

magnesium hydroxide suspension

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 9 0 4-6 8 46

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of

Stre ng th

Stre ng th

MAGNESIUM HYDRO XIDE (UNII: NBZ3QY0 0 4S) (HYDROXIDE ION - UNII:9 159 UV38 1P,

MAGNESIUM CATION - UNII:T6 V3LHY8 38 )

MAGNESIUM

HYDROXIDE

240 0 mg

in 30 mL

Inactive Ingredients

Ingredient Name

Stre ng th

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

XANTHAN GUM (UNII: TTV12P4NEE)

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

METHYLCELLULO SE ( 15 CPS) (UNII: NPU9 M2E6 L8 )

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

TRISO DIUM CITRATE DIHYDRATE (UNII: B22547B9 5K)

GLYCERIN (UNII: PDC6 A3C0 OX)

WATER (UNII: 0 59 QF0 KO0 R)

Product Characteristics

Color

white (Suspensio n)

S core

S hap e

S iz e

Flavor

SPEARMINT

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:0 9 0 4-6 8 46 -

10 in 1 CASE

0 6 /10 /20 19

1

10 in 1 TRAY

1

30 mL in 1 CUP, UNIT-DOSE; Type 0 : No t a Co mbinatio n

Pro duc t

Major Pharmaceuticals

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt331

0 6 /10 /20 19

Labeler -

Major Pharmaceuticals (191427277)

Registrant -

Plastikon Healthcare, LLC (041717941)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Plastiko n Healthcare,

0 417179 41

manufacture(0 9 0 4-6 740 , 0 9 0 4-6 741, 0 9 0 4-6 738 , 0 9 0 4-6 739 , 0 9 0 4-6 8 20 , 0 9 0 4-6 8 40 ,

0 9 0 4-6 8 46 )

Revised: 1/2020

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