Children’s Acetaminophen Drug Facts

Children’s Acetaminophen Drug Facts
SPL v1
SPL
SPL Set ID 8b9456c9-a56b-4748-adb8-c66d6bf072e8
Route
ORAL
Published
Effective Date 2024-09-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg)
Inactive Ingredients
Edetate Disodium Noncrystallizing Sorbitol Solution Carbomer Homopolymer, Unspecified Type Maltitol Methylparaben Propylparaben Xanthan Gum Malic Acid Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-18
Description

Acetaminophen 160 mg

Purpose

Pain reliever-fever reducer

Medication Information

Purpose

Pain reliever-fever reducer

Description

Acetaminophen 160 mg

Uses

temporarily:

  • reduces fever
  • relieves minor aches and pains due to:
  • the common cold
  • flu
  • headache
  • sore throat
  • toothache
Section 42229-5

Distributed by:

Advagen Pharma Ltd.,

East Windsor, NJ 08520, USA

www.advagenpharma.com



Rev. 00, 09/2024

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.

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.

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
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

Principal Display Panel

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

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.

Active Ingredient (in Each 5 Ml)

Acetaminophen 160 mg

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

Structured Label Content

Uses

temporarily:

  • reduces fever
  • relieves minor aches and pains due to:
  • the common cold
  • flu
  • headache
  • sore throat
  • toothache
Section 42229-5 (42229-5)

Distributed by:

Advagen Pharma Ltd.,

East Windsor, NJ 08520, USA

www.advagenpharma.com



Rev. 00, 09/2024

Purpose

Pain reliever-fever reducer

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.

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.

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 your child has ever had an allergic reaction to this product or any of its ingredients
Other Information (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 (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? (Questions or comments?)

+1-866-488-0312

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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

When Using This Product (When using this product)

do not exceed recommended dose (see overdose warning)

Stop Use and Ask A Doctor If (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. (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.

Active Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))

Acetaminophen 160 mg

Ask A Doctor Before Use If Your Child Has (Ask a doctor before use if your child has)

liver disease

Ask A Doctor Or Pharmacist Before Use If Your Child Is (Ask a doctor or pharmacist before use if your child is)

taking the blood thinning drug warfarin

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:35.275573 · Updated: 2026-03-14T23:07:36.685051