Apap Children Chewable Tablets, 80 Mg

Apap Children Chewable Tablets, 80 Mg
SPL v2
SPL
SPL Set ID a5dd9031-a960-4a98-ab71-05b079183f1a
Route
ORAL
Published
Effective Date 2017-10-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (80 mg)
Inactive Ingredients
Aspartame Invert Sugar D&c Red No. 27 Dextrose Fd&c Yellow No. 6 Magnesium Stearate Microcrystalline Cellulose Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: AP;051 Shape: round Color: pink Size: 10 mm Score: 2
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-04-01
Description

Acetaminophen 80 mg

Purpose

Pain reliever/fever reducer

Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 80 mg

Uses
  • temporarily relieves minor aches and pains due to:
  • headache
  • sore throat
  • flu
  • toothache
  • the common cold
  • temporarily reduces fever
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
  • find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • chew before swallowing; this product will soften in mouth for ease of chewing
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • do not give for more than 5 days unless directed by a doctor
Weight (lb) Age (yr) Dose (tablets)*
Under 24 Under 2 Ask a doctor
24-35 2-3 2
36-47 4-5 3
48-59 6-8 4
60-71 9-10 4-5
72-95 11-12 4-6

*or as directed by a doctor

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
Other Information
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • avoid high humidity
  • Phenylketonurics:each tablet contains: phenylalanine 5mg
Inactive Ingredients

aspartame, compressible sugar, D&C red #27(Al lake), dextorse, FD&C yellow #6(Al lake), fruit flavor, magnesium stearate, microcrystaline cellulose, prosweet, stearice acid

Questions Or Comments?

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday

Principal Display Panel

NDC- 54738-092-30 -  APAP 80MG CHEWABLE- 30 TABS

When Using This Product

do not exceed recommended dosage.

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.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredient (in Each Tablet)

Acetaminophen 80 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 relieves minor aches and pains due to:
  • headache
  • sore throat
  • flu
  • toothache
  • the common cold
  • temporarily reduces fever
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
  • find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • chew before swallowing; this product will soften in mouth for ease of chewing
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • do not give for more than 5 days unless directed by a doctor
Weight (lb) Age (yr) Dose (tablets)*
Under 24 Under 2 Ask a doctor
24-35 2-3 2
36-47 4-5 3
48-59 6-8 4
60-71 9-10 4-5
72-95 11-12 4-6

*or as directed by a doctor

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 is allergic to acetaminophen or any of the inactive ingredients in this product
Other Information (Other information)
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • avoid high humidity
  • Phenylketonurics:each tablet contains: phenylalanine 5mg
Inactive Ingredients (Inactive ingredients)

aspartame, compressible sugar, D&C red #27(Al lake), dextorse, FD&C yellow #6(Al lake), fruit flavor, magnesium stearate, microcrystaline cellulose, prosweet, stearice acid

Questions Or Comments? (Questions or comments?)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday

Principal Display Panel (Principal display panel)

NDC- 54738-092-30 -  APAP 80MG CHEWABLE- 30 TABS

When Using This Product (When using this product)

do not exceed recommended dosage.

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.)

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Acetaminophen 80 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: 2026-02-15T11:56:26.107443 · Updated: 2026-03-14T22:54:54.026912