Hst148

Hst148
SPL v2
SPL
SPL Set ID 22f63d62-c941-5b8f-e063-6394a90aeecd
Route
ORAL
Published
Effective Date 2024-09-25
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 DRUG Active Since 2024-02-01

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
  • temporarily reduces fever
Purposes

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.

Directions

Chew tablets thoroughly before swallowing.

This product does not contain directions or complete

warnings for adults.


Follow dosage on table or use as doctor directs. If possible

use weight to dose; otherwise use age. Give every 4 hours

as needed; do not give more than 5 doses in 24 hours.

Administer only under adult supervision.

DO NOT EXCEED DOSE SHOWN

See Overdose Warning.

Weight (lb)

Under 24 24-35 36-47 48-59 60-71 72-95
Age

Under 2

2-3 4-5 6-8 9-10 11
Tablets Ask a doctor 2 3 4 5 6

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
  • TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.
  • store at 20°C-25°C (68°F-77°F)F); avoid high humidity
  • Keep tightly closed
  • Phenylketonurics: contains phenylalanine 5mg per tablet.
Inactive Ingredients

Aspartame (contains phenylalanine), cellulose, D&C Red #27, Dextrose, FD&C Yellow #6, fruit flavor, magnesium stearate,

Prosweet, stearic acid, sugar

Questions Or Comments?

1-800-540-3765

Principal Display Panel

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.

Quick 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
  • temporarily reduces fever
Purposes

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.

Directions

Chew tablets thoroughly before swallowing.

This product does not contain directions or complete

warnings for adults.


Follow dosage on table or use as doctor directs. If possible

use weight to dose; otherwise use age. Give every 4 hours

as needed; do not give more than 5 doses in 24 hours.

Administer only under adult supervision.

DO NOT EXCEED DOSE SHOWN

See Overdose Warning.

Weight (lb)

Under 24 24-35 36-47 48-59 60-71 72-95
Age

Under 2

2-3 4-5 6-8 9-10 11
Tablets Ask a doctor 2 3 4 5 6

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)
  • TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.
  • store at 20°C-25°C (68°F-77°F)F); avoid high humidity
  • Keep tightly closed
  • Phenylketonurics: contains phenylalanine 5mg per tablet.
Inactive Ingredients (Inactive ingredients)

Aspartame (contains phenylalanine), cellulose, D&C Red #27, Dextrose, FD&C Yellow #6, fruit flavor, magnesium stearate,

Prosweet, stearic acid, sugar

Questions Or Comments? (Questions or comments?)

1-800-540-3765

Principal Display Panel (Principal display panel)

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.

Quick 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)