CHILDRENS ACETAMINOPHEN- acetaminophen suspension

Childrens Acetaminophen by

Drug Labeling and Warnings

Childrens Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Advagen Pharma Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Purpose

Pain reliever-fever reducer

Uses

temporarily:

• reduces fever
• relieves minor aches and pains due to:
• the common cold
• flu
• headache
• sore throat
• toothache

Warnings

Liver warning:This product 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.

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

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 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 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 even if you do not notice any signs or symptoms.

Directions

• this product does not contain directions or complete warnings for adult use
• do not give more than directed (see overdose warning)
• shake well before using
• mL = milliliter
• find right dose on chart below. If possible, use weight to dose; otherwise, use age.
• remove the child protective cap and squeeze your child’s dose into the dosing cup
• repeat dose every 4 hours while symptoms last
• do not give 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

*or as directed by a doctor

Attention:use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information

• each 5 mL contains:sodium 4 mg
• store at 20-25 °C (68-77 °F)
• do not use if tamper-evident ring is broken or missing

Inactive ingredients

edetate disodium, non crystallizing sorbitol solution, carbomer homopolymer, maltitol solution, methylparaben, propylparaben, xanthan gum, sucralose, orange flavor, malic acid, sodium hydroxide, purified water

Questions or comments?

+1-866-488-0312

SPL UNCLASSIFIED SECTION

Distributed by:

Advagen Pharma Ltd.,

East Windsor, NJ 08520, USA

www.advagenpharma.com

Rev. 00, 09/2024

PRINCIPAL DISPLAY PANEL

Acetaminophen Oral Suspension 16mg/5mL - NDC: 72888-459-01 - 118mL Carton Label

INGREDIENTS AND APPEARANCE

CHILDRENS ACETAMINOPHEN 
acetaminophen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72888-459
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)
NONCRYSTALLIZING SORBITOL SOLUTION (UNII: 9E0S3UM200)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
MALTITOL (UNII: D65DG142WK)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
XANTHAN GUM (UNII: TTV12P4NEE)
MALIC ACID (UNII: 817L1N4CKP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	ORANGE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72888-459-01	1 in 1 CARTON	02/18/2025
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	02/18/2025

Labeler - Advagen Pharma Limited (051627256)