ACETAMINOPHEN suspension

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

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Active ingredient:
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)
Available from:
Precision Dose, Inc.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/fever reducer temporarily: - reduces fever - relieves minor aches and pains due to: the common cold flu headache sore throat toothache - the common cold - flu - headache - sore throat - toothache
Product summary:
NDC 68094-130-58 2.5 mL per unit dose syringe Fifty (50) syringes per shipper NDC 68094-231-58 5 mL per unit dose syringe Fifty (50) syringes per shipper NDC 68094-231-61 5 mL per unit dose cup One hundred (100) cups per shipper NDC 68094-231-62 5 mL per unit dose cup Thirty (30) cups per shipper NDC 68094-330-61 10.15 mL per unit dose cup One hundred (100) cups per shipper NDC 68094-330-62 10.15 mL per unit dose cup Thirty (30) cups per shipper NDC 68094-030-62 20.3 mL per unit dose cup Thirty (30) cups per shipper
Authorization status:
OTC monograph not final
Authorization number:
68094-030-59, 68094-030-62, 68094-231-59, 68094-231-61, 68094-231-62, 68094-330-59, 68094-330-61, 68094-330-62

ACETAMINOPHEN- acetaminophen suspension

Precision Dose, Inc.

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.

----------

Acetaminophen Oral Suspension

Drug Facts

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Purpos e

Pain reliever/fever reducer

Us es

temporarily:

reduces fever

relieves minor aches and pains due to:

the common cold

headache

sore throat

toothache

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if

adult takes more than 4,000 mg of acetaminophen in 24 hours

child takes more than 5 doses in 24 hours

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.

Sore throat warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache,

rash, nausea, or vomiting, consult a doctor promptly.

Do not use

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 have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if the user has liver disease

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

When using this product do not exceed recommended dose (see overdose warning)

Stop use and ask a doctor if

pain gets worse or lasts more than 10 days (for adults) or 5 days (for children)

fever gets worse or lasts more than 3 days

new symptoms occur

redness or swelling is present

These could be signs of a serious condition.

do not give this product to children for the pain of arthritis unless directed by a doctor

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

Keep out of reach of children.

Overdose warning

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

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

or symptoms.

Directions

Use as directed per healthcare professional.

do not take more than directed (see overdose warning)

shake well before using

find the right dose on chart below. If possible, use weight to dose; otherwise, use age.

repeat dose every 4 hours while symptoms last

do not take more than 5 times in 24 hours

Weight (lb)

Age (yr)

Dose (mL)

Under 24

Under 2 years

ask a doctor

24-35

2-3 years

5 mL

36-47

4-5 years

7.5 mL

48-59

6-8 years

10 mL

60-71

9-10 years

12.5 mL

72-95

11 years

15 mL

Over 96

adults and children 12 years

and over

20 mL

Other information

each 5 mL contains: sodium 3 mg

store at 20-25°C (68-77°F)

*

or as directed by a doctor

Inactive ingredients

anhydrous citric acid, butylparaben, calcium sulfate, carrageenan, D&C red #33, FD&C blue #1, flavor,

glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose and

carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution,

tribasic sodium phosphate

Alcohol Free, Aspirin Free, Gluten Free, Ibuprofen Free

How Supplied

NDC 68094-130-58

2.5 mL per unit dose syringe

Fifty (50) syringes per shipper

NDC 68094-231-58

5 mL per unit dose syringe

Fifty (50) syringes per shipper

NDC 68094-231-61

5 mL per unit dose cup

One hundred (100) cups per shipper

NDC 68094-231-62

5 mL per unit dose cup

Thirty (30) cups per shipper

NDC 68094-330-61

10.15 mL per unit dose cup

One hundred (100) cups per shipper

NDC 68094-330-62

10.15 mL per unit dose cup

Thirty (30) cups per shipper

NDC 68094-030-62

20.3 mL per unit dose cup

Thirty (30) cups per shipper

For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email druginfo@precisiondose.com

Distributed By

Perrigo

Allegan, MI 49010

Packaged By

Precision Dose, Inc.

South Beloit, IL 61080

LI1263 Rev. 10/19

PRINCIPAL DISPLAY PANEL - 20.3 mL Cup Label

NDC 68094-030-59

PrecisionDose™

ACETAMINOPHEN

Oral Suspension

650 mg/20.3 mL

Delivers 20.3 mL Shake Well

Each 5 mL contains Sodium 3 mg

Alcohol Free

Aspirin Free

Gluten Free

Ibuprofen Free

Hospital Use Only

Store at 20°-25°C (68°-77°F)

Pkg. By: Precision Dose, Inc.

S. Beloit, IL 61080

1262 R0

PRINCIPAL DISPLAY PANEL - 10.15 mL Cup Label

NDC 68094-330-59

PrecisionDose™

ACETAMINOPHEN

Oral Suspension

325 mg/10.15 mL

Delivers 10.15 mL Shake Well

Each 5 mL contains Sodium 3 mg

Alcohol Free

Aspirin Free

Gluten Free

Ibuprofen Free

Hospital Use Only

Store at 20°-25°C (68°-77°F)

Pkg. By: Precision Dose, Inc.

South Beloit, IL 61080

1303 R0

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

NDC 68094-231-59

PrecisionDose™

ACETAMINOPHEN

Oral Suspension

160 mg/5 mL

Pkg: Precision Dose, Inc., S. Beloit, IL 61080

ACETAMINOPHEN

acetaminophen suspension

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 8 0 9 4-0 30

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Aceta mino phen (UNII: 36 2O9 ITL9 D) (Acetamino phen - UNII:36 2O9 ITL9 D)

Ac e ta mino phe n

6 50 mg in 20 .3 mL

Inactive Ingredients

Ingredient Name

Stre ng th

a nhydro us citric a cid (UNII: XF417D3PSL)

butylpa ra ben (UNII: 3QPI1U3FV8 )

ca lcium sulfa te, unspecified fo rm (UNII: WAT0 DDB50 5)

ca rra g eena n (UNII: 5C6 9 YCD2YJ)

D&C red no . 3 3 (UNII: 9 DBA0 SBB0 L)

FD&C blue no . 1 (UNII: H3R47K3TBD)

g lycerin (UNII: PDC6 A3C0 OX)

hig h fructo se co rn syrup (UNII: XY6 UN3QB6 S)

micro crysta lline cellulo se (UNII: OP1R32D6 1U)

ca rbo xymethylcellulo se so dium, unspecified fo rm (UNII: K6 79 OBS311)

pro pylene g lyco l (UNII: 6 DC9 Q16 7V3)

wa ter (UNII: 0 59 QF0 KO0 R)

so dium benzo a te (UNII: OJ245FE5EU)

so rbito l (UNII: 50 6 T6 0 A25R)

so dium pho spha te, triba sic (UNII: A752Q30 A6 X)

Product Characteristics

Color

PURPLE

S core

S hap e

S iz e

Flavor

GRAPE

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 8 0 9 4-0 30 -

3 in 1 CASE

0 9 /0 6 /20 19

1

10 in 1 TRAY

1

NDC:6 8 0 9 4-0 30 -

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 MONOGRAPH NOT FINAL part343

0 9 /0 6 /20 19

ACETAMINOPHEN

acetaminophen suspension

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 8 0 9 4-330

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Aceta mino phen (UNII: 36 2O9 ITL9 D) (Acetamino phen - UNII:36 2O9 ITL9 D)

Ac e ta mino phe n

325 mg in 10 .15 mL

Inactive Ingredients

Ingredient Name

Stre ng th

a nhydro us citric a cid (UNII: XF417D3PSL)

butylpa ra ben (UNII: 3QPI1U3FV8 )

ca lcium sulfa te, unspecified fo rm (UNII: WAT0 DDB50 5)

ca rra g eena n (UNII: 5C6 9 YCD2YJ)

D&C red no . 3 3 (UNII: 9 DBA0 SBB0 L)

FD&C blue no . 1 (UNII: H3R47K3TBD)

g lycerin (UNII: PDC6 A3C0 OX)

hig h fructo se co rn syrup (UNII: XY6 UN3QB6 S)

micro crysta lline cellulo se (UNII: OP1R32D6 1U)

ca rbo xymethylcellulo se so dium, unspecified fo rm (UNII: K6 79 OBS311)

pro pylene g lyco l (UNII: 6 DC9 Q16 7V3)

wa ter (UNII: 0 59 QF0 KO0 R)

so dium benzo a te (UNII: OJ245FE5EU)

so rbito l (UNII: 50 6 T6 0 A25R)

so dium pho spha te, triba sic (UNII: A752Q30 A6 X)

Product Characteristics

Color

PURPLE

S core

S hap e

S iz e

Flavor

GRAPE

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 8 0 9 4-330 -

3 in 1 CASE

0 1/15/20 20

1

10 in 1 TRAY

1

NDC:6 8 0 9 4-330 -

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

Pro duc t

2

NDC:6 8 0 9 4-330 -

10 in 1 CASE

0 1/15/20 20

2

10 in 1 TRAY

2

NDC:6 8 0 9 4-330 -

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 MONOGRAPH NOT FINAL part343

0 1/15/20 20

ACETAMINOPHEN

acetaminophen suspension

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 8 0 9 4-231

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Aceta mino phen (UNII: 36 2O9 ITL9 D) (Acetamino phen - UNII:36 2O9 ITL9 D)

Ac e ta mino phe n

16 0 mg in 5 mL

Inactive Ingredients

Ingredient Name

Stre ng th

a nhydro us citric a cid (UNII: XF417D3PSL)

butylpa ra ben (UNII: 3QPI1U3FV8 )

ca lcium sulfa te, unspecified fo rm (UNII: WAT0 DDB50 5)

ca rra g eena n (UNII: 5C6 9 YCD2YJ)

D&C red no . 3 3 (UNII: 9 DBA0 SBB0 L)

FD&C blue no . 1 (UNII: H3R47K3TBD)

g lycerin (UNII: PDC6 A3C0 OX)

hig h fructo se co rn syrup (UNII: XY6 UN3QB6 S)

micro crysta lline cellulo se (UNII: OP1R32D6 1U)

ca rbo xymethylcellulo se so dium, unspecified fo rm (UNII: K6 79 OBS311)

pro pylene g lyco l (UNII: 6 DC9 Q16 7V3)

wa ter (UNII: 0 59 QF0 KO0 R)

so dium benzo a te (UNII: OJ245FE5EU)

so rbito l (UNII: 50 6 T6 0 A25R)

so dium pho spha te, triba sic (UNII: A752Q30 A6 X)

Product Characteristics

Color

PURPLE

S core

Precision Dose, Inc.

S hap e

S iz e

Flavor

GRAPE

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 8 0 9 4-231-

3 in 1 CASE

0 4/0 1/20 20

1

10 in 1 TRAY

1

NDC:6 8 0 9 4-231-

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

Pro duc t

2

NDC:6 8 0 9 4-231-

10 in 1 CASE

0 4/0 1/20 20

2

10 in 1 TRAY

2

NDC:6 8 0 9 4-231-

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 MONOGRAPH NOT FINAL part343

0 4/0 1/20 20

Labeler -

Precision Dose, Inc. (035886746)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Precisio n Do se, Inc.

0 358 8 6 746

REPACK(6 8 0 9 4-0 30 , 6 8 0 9 4-330 , 6 8 0 9 4-231)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

L Perrigo Co mpany

0 0 6 0 13346

MANUFACTURE(6 8 0 9 4-0 30 , 6 8 0 9 4-330 , 6 8 0 9 4-231)

Revised: 3/2020

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