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

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 80 mg


Medication Information

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.

Active Ingredient

Acetaminophen 80 mg

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

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

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

Description

Acetaminophen 80 mg

Principal Display Panel

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

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
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

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.

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

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.

Active Ingredient (Active ingredient (in each tablet))

Acetaminophen 80 mg

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

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

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

Principal Display Panel (Principal display panel)

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

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
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

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.

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

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