GUAIFENESIN AND DEXTROMETHORPHAN ORAL SOLUTION- guaifenesin dextromethorphan hydrobromide oral solution solution

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

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Active ingredient:
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)
Available from:
Major Pharmaceuticals
Administration route:
ORAL
Prescription type:
OTC DRUG
Authorization status:
OTC monograph final
Authorization number:
0904-6844-70, 0904-6980-72

GUAIFENESIN AND DEXTROMETHORPHAN ORAL SOLUTION- guaifenesin

dextromethorphan hydrobromide oral solution solution

GUAIFENESIN AND DEXTROMETHORPHAN ORAL SOLUTION- guaifenesin

dextromethorphan hydrobromide oral solution solution

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

Guaifenesin DM 200/20 mg/ 10 mL

Guaifenesin DM 100/10 mg/ 5 mL

Guaifenesin Dextromethorphan hydrobromide 100/10 mg/5 mL Cup

NCD 0904-6844-70

Guaifenesin and Detromethorphan Oral Solution

100-10 mg/5 mL

Delivers 5 mL

See Insert

For Institutional Use Only

MAJOR® PHARMACEUTICALS

Livonia, MI 48152

Sugar Free - Alcohol Free

Guaifenesin Dextromethorphan hydrobromide 100/10 mg/5 mL cup

Directions

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

shake well before use

Age (yr)

Dose (mL)

adults and children

12 years and over

10 mL every 4 hours or

15 mL every 6 hours

Max dose is 60 mL in

24 hr

children 6 years to

under 12 years

5 mL every 4 hours

Max does is 30 mL in

24 hr

under 6 years

Ask a doctor

Guaifenesin Dextromethorphan hydrobromide 100/10 mg/5 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)

Guaifenesin Dextromethorphan hydrobromide 100/10 mg/5 mL

Guaifenesin Dextromethorphan hydrobromide 100/10 mg/5 mL

Warnings

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks

after stopping the MAOI drug.

Ask a doctor before use if you have

cough that occurs with too much phlegm (mucus)

cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or

emphysema

_________________________________________________________________

Ask a doctor or pharmacist before use if you are taking any other drug.

___________________________________________________________________

Stop use and ask a doctor if

your cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent

headache.

Guaifenesin Dextromethorphan hydrobromide 100/10 mg/ 5 mL

Inactive ingredients citric acid, glycerin, propylene glycol, purified water, saccharin sodium, sodium

benzoate, sorbitol, sucralose, xanthan gum

Guaifenesin Dextromethorphan hydrobromide 100/10 mg/ 5 mL

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

Guaifenesin Dextromethorphan hydrobromide 100/10 mg/5 mL

Active ingredients (in each 5 mL cup)

Guaifenesin 100 mg

Dextromethorphan hydrobromide 10 mg

Guaifenesin Dextromethorphan hydrobromide 100/10 mg/5 mL

Purpose

Expectorant

Cough Suppressant

Guaifenesin Dextromethorphan hydrobromide 100/10 mg/ 5 mL

Other information

each 5 mL contains: sodium 20 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

Guaifenesin Dextromethorphan hydrobromide 200/20 mg/10mL

NCD 0904-6980-72

Guaifenesin and Detromethorphan Oral Solution

200-20 mg/10 mL

Delivers 10 mL

See Insert

For Institutional Use Only

MAJOR® PHARMACEUTICALS

Livonia, MI 48152

Sugar Free - Alcohol Free

Guaifenesin Dextromethorphan hydrobromide 200/20 mg/ 10 mL

Directions

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

shake well before use

Age (yr)

Dose (mL)

adults and children 12

years and over

10 mL every 4

hours

Max dose is 60

mL in 24 hr

children under 12 years

Ask a doctor

Guaifenesin Dextromethorphan hydrobromide 200/20 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)

Guaifenesin Dextromethorphan hydrobromide 200/20 mg/10 mL

Warnings

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks

after stopping the MAOI drug.

Ask a doctor before use if you have

cough that occurs with too much phlegm (mucus)

cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or

emphysema

_________________________________________________________________

Ask a doctor or pharmacist before use if you are taking any other drug.

___________________________________________________________________

Stop use and ask a doctor if

your cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent

headache.

you are hypersensitive to any of the ingredients

___________________________________________________________________

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

Guaifenesin Dextromethorpan hydrobromide 200/20 mg/10 mL

Inactive ingredients citric acid, glycerin, propylene glycol, purified water, saccharin sodium, sodium

benzoate, sorbitol, sucralose, xanthan gum

Guaifenesin Dextromethorphan hydrobromide 200/20 mg/10 mL

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

Guaifenesin Dextromethorphan hydrobromide 200/20 mg/10 mL

Active ingredients (in each 10 mL cup)

Guaifenesin 200 mg

Dextromethorphan hydrobromide 20 mg

Guaifenesin Dextromethorphan hydrobromide 200/20 mg/ 10 mL

Purpose

Expectorant

Cough Suppressant

Guaifenesin Dextromethorphan hydrobromide 200/20 mg/ 10 mL

Other information

each 10 mL contains: sodium 40 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

Guaifenesin Dextromethorphan hydrobromide 200/20 mg/10 mL

GUAIFENESIN AND DEXTROMETHORPHAN ORAL SOLUTION

guaifenesin dextromethorphan hydrobromide oral solution solution

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 9 0 4-6 8 44

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DEXTRO METHO RPHAN HYDRO BRO MIDE (UNII: 9 D2RTI9 KYH)

(DEXTROMETHORPHAN - UNII:7355X3ROTS)

DEXTROMETHORPHAN

HYDROBROMIDE

10 mg

in 5 mL

GUAIFENESIN (UNII: 49 5W7451VQ) (GUAIFENESIN - UNII:49 5W7451VQ)

GUAIFENESIN

10 0 mg

in 5 mL

Inactive Ingredients

Ingredient Name

Stre ng th

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

XANTHAN GUM (UNII: TTV12P4NEE)

GLYCERIN (UNII: PDC6 A3C0 OX)

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

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

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

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

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

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 8 44-

10 in 1 CARTON

0 9 /20 /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 final

pa rt341

0 9 /20 /20 19

GUAIFENESIN AND DEXTROMETHORPHAN ORAL SOLUTION

guaifenesin dextromethorphan hydrobromide oral solution solution

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 9 0 4-6 9 8 0

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

GUAIFENESIN (UNII: 49 5W7451VQ) (GUAIFENESIN - UNII:49 5W7451VQ)

GUAIFENESIN

20 0 mg

in 10 mL

DEXTRO METHO RPHAN HYDRO BRO MIDE (UNII: 9 D2RTI9 KYH)

(DEXTROMETHORPHAN - UNII:7355X3ROTS)

DEXTROMETHORPHAN

HYDROBROMIDE

20 mg

in 10 mL

Inactive Ingredients

Ingredient Name

Stre ng th

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

XANTHAN GUM (UNII: TTV12P4NEE)

GLYCERIN (UNII: PDC6 A3C0 OX)

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

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

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

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

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

Major Pharmaceuticals

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 9 8 0 -

10 in 1 CARTON

0 9 /20 /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 rt341

0 9 /20 /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, LLC

0 417179 41

manufacture(0 9 0 4-6 9 8 0 , 0 9 0 4-6 8 44)

Revised: 9/2019

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