CHILDRENS ACETAMINOPHEN- acetaminophen suspension

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

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Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)
Available from:
Cardinal Health
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/fever reducer Temporarily:
Authorization status:
OTC monograph not final
Authorization number:
55154-5787-5

CHILDRENS ACETAMINOPHEN- acetaminophen suspension

Cardinal Health

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.

----------

Children's Acetaminophen Oral Suspension

Alcohol Free / Aspirin Free

Drug Facts

Active ingredient

(in each 5 mL teaspoonful)

Acetaminophen 160 mg

Purpos e

Pain reliever/fever reducer

Us es

Temporarily:

Warnings

Liver warning:

This product contains contains acetaminophen. Severe liver damage may occur if your

child takes:

more than 5 doses in 24 hours, which is the maximum daily amount

with other drugs containing acetaminophen

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

reduces fever

relieves minor aches and pain due to:

the common cold

headache

sore throat

toothache

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 your child is allergic to acetaminophen or any of the inactive ingredients in this product.

Ask a doctor before use if your child has liver disease

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

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

Stop use and ask a doctor if:

pain gets worse or lasts more than 5 days

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.

Keep out of the 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 children even if you do

not notice any sign or symptoms

Directions

Weight (lbs)

Age (yr)

Dose (mL or tsp)

Under 24

Under 2

Ask a doctor

24-35

2-3 years

5 mL (1 tsp)

36-47

4-5 years

7.5 mL (1 ½ tsp)

48-59

6-8 years

10 mL (2 tsp)

60-71

9-10 years

12.5 mL (2 ½ tsp)

72-95

11 years

15 mL (3 tsp)

Other information

NDC 0121-1781-05: 5 mL unit dose cup

this product does not contain directions or complete warnings for adult use

do not take more than directed (see overdose warning)

shake well before using

mL = milliliter; tsp = teaspoonful

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 give more than 5 times in 24 hours

or as directed by a doctor

each 5 mL contains: sodium 2 mg

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]

protect from freezing

a red, berry flavored suspension supplied in the following oral dosage form:

NDC 0121-1781-00: Case contains 100 unit dose cups of 5 mL (0121-1781-05) packaged in 10 trays of

10 unit dose cups each.

Inactive ingredients

Acesulfame K, butylparaben, citric acid, high fructose corn syrup, FD&C Red No. 40, flavoring,

glycerin, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, veegum

and xanthan gum.

Questions or comments?

Call 1-800-845-8210.

You may also report serious side effects to this phone number.

Pharmaceutical

Associates, Inc. Greenville, SC 29605

www.paipharma.com

Distributed by:

Cardinal Health

Dublin, OH 43017

L55345730619

R07/19

Principal Display Panel

Children’s Acetaminophen Oral Suspension

160 mg/5 mL

5 Cups

CHILDRENS ACETAMINOPHEN

acetaminophen suspension

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:55154-578 7(NDC:0 121-178 1)

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

ACESULFAME (UNII: MA3UYZ6 K1H)

BUTYLPARABEN (UNII: 3QPI1U3FV8 )

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

Cardinal Health

CO RN SYRUP (UNII: 9 G5L16 BK6 N)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

GLYCERIN (UNII: PDC6 A3C0 OX)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

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

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

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

XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics

Color

re d

S core

S hap e

S iz e

Flavor

BERRY

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:55154-578 7-

5 in 1 BAG

0 9 /17/20 0 7

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 9 /17/20 0 7

Labeler -

Cardinal Health (603638201)

Revised: 7/2020

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