Gc222

Gc222
SPL v6
SPL
SPL Set ID 7a7b6318-b7d6-31b1-e053-2991aa0abf25
Route
ORAL
Published
Effective Date 2011-05-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Povidone Sodium Starch Glycolate Type A Corn Starch, Corn Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: AZ328 Shape: capsule Color: white Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-08-01

Description

Acetaminophen 500 mg

Purpose

Pain Reliever/Fever Reducer


Medication Information

Purpose

Pain Reliever/Fever Reducer

Description

Acetaminophen 500 mg

Uses
  • temporarily relieves minor aches and pains
  • temporarily reduces fever
Section 50565-1

Keep out of reach of children. 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.

Warnings

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if you take:

  • more than 8 caplets (4,000 mg of acetaminophen) in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

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.

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 you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if you have liver disease.

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptom occur
  • redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Directions
  • do not take more than directed
  • adults and children 12 years and over: take 2 caplets

    every 6 hours, as needed. Do not take more than 6

    caplets in 24 hours. Do not take for more than 10 days unless directed by a doctor.
  • children under 12 years: ask a doctor
Package Label

Active Ingredient

Acetaminophen 500 mg

Other Information
  • store at 20⁰C-25⁰C (68⁰F-77⁰F)
Inactive Ingredients

corn starch, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions Or Comments?

1-800-540-3765


Structured Label Content

Uses
  • temporarily relieves minor aches and pains
  • temporarily reduces fever
Section 50565-1 (50565-1)

Keep out of reach of children. 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.

Purpose

Pain Reliever/Fever Reducer

Warnings

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if you take:

  • more than 8 caplets (4,000 mg of acetaminophen) in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

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.

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 you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if you have liver disease.

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptom occur
  • redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Directions
  • do not take more than directed
  • adults and children 12 years and over: take 2 caplets

    every 6 hours, as needed. Do not take more than 6

    caplets in 24 hours. Do not take for more than 10 days unless directed by a doctor.
  • children under 12 years: ask a doctor
Package Label (Package label)

Active Ingredient (Active ingredient)

Acetaminophen 500 mg

Other Information
  • store at 20⁰C-25⁰C (68⁰F-77⁰F)
Inactive Ingredients (Inactive ingredients)

corn starch, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions Or Comments? (Questions or comments?)

1-800-540-3765


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)