Gc201

Gc201
SPL v1007
SPL
SPL Set ID 31a97a6a-e5c8-429a-b497-330f0d84777d
Route
ORAL
Published
Effective Date 2024-07-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: M2A457344 Shape: round Color: white Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 1989-01-01

Description

Acetaminophen 500 mg

Purpose

Pain Reliever/Fever Reducer

How Supplied

Acetaminophen 500 mg Tablet NDC: 63629-1516-1: 20 Tablets in a BOTTLE NDC: 63629-1516-2: 15 Tablets in a BOTTLE NDC: 63629-1516-3: 40 Tablets in a BOTTLE NDC: 63629-1516-4: 100 Tablets in a BOTTLE NDC: 63629-1516-5: 30 Tablets in a BOTTLE NDC: 63629-1516-6: 45 Tablets in a BOTTLE NDC: 63629-1516-7: 50 Tablets in a BOTTLE NDC: 63629-1516-8: 60 Tablets in a BOTTLE NDC: 63629-1516-9: 90 Tablets in a BOTTLE NDC: 63629-1516-0: 250 Tablets in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504


Medication Information

Purpose

Pain Reliever/Fever Reducer

How Supplied

Acetaminophen 500 mg Tablet

  • NDC: 63629-1516-1: 20 Tablets in a BOTTLE
  • NDC: 63629-1516-2: 15 Tablets in a BOTTLE
  • NDC: 63629-1516-3: 40 Tablets in a BOTTLE
  • NDC: 63629-1516-4: 100 Tablets in a BOTTLE
  • NDC: 63629-1516-5: 30 Tablets in a BOTTLE
  • NDC: 63629-1516-6: 45 Tablets in a BOTTLE
  • NDC: 63629-1516-7: 50 Tablets in a BOTTLE
  • NDC: 63629-1516-8: 60 Tablets in a BOTTLE
  • NDC: 63629-1516-9: 90 Tablets in a BOTTLE
  • NDC: 63629-1516-0: 250 Tablets in a BOTTLE

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

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.

Section 51945-4

Acetaminophen 500 mg Tablet

Warnings

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 8 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 1 to 2 tablets every 4 to 6 hours, as needed; not more than 6 tablets 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
  • TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.
  • store at 20⁰C-25⁰C (68⁰F-77⁰F)
Active Ingredients

Acetaminophen 500 mg

Inactive Ingredients

povidone, sodium starch glycolate, starch, 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.

Section 51945-4 (51945-4)

Acetaminophen 500 mg Tablet

Purpose

Pain Reliever/Fever Reducer

Warnings

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 8 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 1 to 2 tablets every 4 to 6 hours, as needed; not more than 6 tablets in 24 hours. Do not take for more than 10 days unless directed by a doctor
  • children under 12 years: ask a doctor
How Supplied (HOW SUPPLIED)

Acetaminophen 500 mg Tablet

  • NDC: 63629-1516-1: 20 Tablets in a BOTTLE
  • NDC: 63629-1516-2: 15 Tablets in a BOTTLE
  • NDC: 63629-1516-3: 40 Tablets in a BOTTLE
  • NDC: 63629-1516-4: 100 Tablets in a BOTTLE
  • NDC: 63629-1516-5: 30 Tablets in a BOTTLE
  • NDC: 63629-1516-6: 45 Tablets in a BOTTLE
  • NDC: 63629-1516-7: 50 Tablets in a BOTTLE
  • NDC: 63629-1516-8: 60 Tablets in a BOTTLE
  • NDC: 63629-1516-9: 90 Tablets in a BOTTLE
  • NDC: 63629-1516-0: 250 Tablets in a BOTTLE

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Other Information
  • TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.
  • store at 20⁰C-25⁰C (68⁰F-77⁰F)
Active Ingredients

Acetaminophen 500 mg

Inactive Ingredients

povidone, sodium starch glycolate, starch, stearic acid.

Questions Or Comments? (Questions or comments?)

1-800-540-3765


Advanced Ingredient Data


Raw Label Data

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