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

Purpose

Pain Reliever/Fever Reducer

Description

Acetaminophen 500 mg


Medication Information

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.

Uses
  • temporarily relieves minor aches and pains
  • temporarily reduces fever
Purpose

Pain Reliever/Fever Reducer

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

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

Description

Acetaminophen 500 mg

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.

Package Label

Active Ingredient

Acetaminophen 500 mg

Questions Or Comments?

1-800-540-3765


Structured Label Content

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.

Uses
  • temporarily relieves minor aches and pains
  • temporarily reduces fever
Purpose

Pain Reliever/Fever Reducer

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

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

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.

Package Label (Package label)

Active Ingredient (Active ingredient)

Acetaminophen 500 mg

Questions Or Comments? (Questions or comments?)

1-800-540-3765


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)