Gc 102

Gc 102
SPL v4
SPL
SPL Set ID 7c73fc75-af9b-177c-e053-2a91aa0ada56
Route
ORAL
Published
Effective Date 2019-03-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg)
Inactive Ingredients
Stearic Acid Povidone Sodium Starch Glycolate Type A Potato Starch, Corn

Identifiers & Packaging

Pill Appearance
Imprint: GC101 Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 1989-01-01

Description

Acetaminophen 325 mg

Purpose

Pain Reliever/Fever Reducer


Medication Information

Purpose

Pain Reliever/Fever Reducer

Description

Acetaminophen 325 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.

The maximum daily dose of this product is 10 tablets

in 24 hours. Severe liver damage may occur if you take:

  • more than 12 tablets (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.

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 tablets every 4-6 hours, as needed; not more than 10 tablets in 24 hours
  • children under 12 years: ask a doctor
Package Label

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

Acetaminophen 325 mg

Inactive Ingredients

povidone, sodium starch glycolate, starch stearic acid.


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.

The maximum daily dose of this product is 10 tablets

in 24 hours. Severe liver damage may occur if you take:

  • more than 12 tablets (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.

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 tablets every 4-6 hours, as needed; not more than 10 tablets in 24 hours
  • children under 12 years: ask a doctor
Package Label

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

Acetaminophen 325 mg

Inactive Ingredients

povidone, sodium starch glycolate, starch stearic acid.


Advanced Ingredient Data


Raw Label Data

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