Gc101 (104)

Gc101 (104)
SPL v103
SPL
SPL Set ID 84319ef4-96b2-41d4-b094-844902a86098
Route
ORAL
Published
Effective Date 2024-07-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: 44;104 Shape: round Color: white Size: 10 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-04-01

Description

Acetaminophen 325 mg

Purpose

Pain Reliever/Fever Reducer

How Supplied

Acetaminophen 325 mg Tablet NDC: 71335-1847-1: 20 Tablets in a BOTTLE NDC: 71335-1847-2: 100 Tablets in a BOTTLE NDC: 71335-1847-3: 30 Tablets in a BOTTLE NDC: 71335-1847-4: 2 Tablets in a BOTTLE NDC: 71335-1847-5: 6 Tablets in a BOTTLE NDC: 71335-1847-6: 10 Tablets in a BOTTLE NDC: 71335-1847-7: 60 Tablets in a BOTTLE NDC: 71335-1847-8: 90 Tablets in a BOTTLE NDC: 71335-1847-9: 40 Tablets in a BOTTLE NDC: 71335-1847-0: 24 Tablets in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504


Medication Information

Purpose

Pain Reliever/Fever Reducer

How Supplied

Acetaminophen 325 mg Tablet

  • NDC: 71335-1847-1: 20 Tablets in a BOTTLE
  • NDC: 71335-1847-2: 100 Tablets in a BOTTLE
  • NDC: 71335-1847-3: 30 Tablets in a BOTTLE
  • NDC: 71335-1847-4: 2 Tablets in a BOTTLE
  • NDC: 71335-1847-5: 6 Tablets in a BOTTLE
  • NDC: 71335-1847-6: 10 Tablets in a BOTTLE
  • NDC: 71335-1847-7: 60 Tablets in a BOTTLE
  • NDC: 71335-1847-8: 90 Tablets in a BOTTLE
  • NDC: 71335-1847-9: 40 Tablets in a BOTTLE
  • NDC: 71335-1847-0: 24 Tablets in a BOTTLE

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

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.

Section 51945-4

Acetaminophen 325 mg Tablet

Warnings

Liver warning:

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

  • more than 4,000 mg (12 tablets) 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. 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 325 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 325 mg Tablet

Purpose

Pain Reliever/Fever Reducer

Warnings

Liver warning:

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

  • more than 4,000 mg (12 tablets) 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. 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 325 mg Tablet

  • NDC: 71335-1847-1: 20 Tablets in a BOTTLE
  • NDC: 71335-1847-2: 100 Tablets in a BOTTLE
  • NDC: 71335-1847-3: 30 Tablets in a BOTTLE
  • NDC: 71335-1847-4: 2 Tablets in a BOTTLE
  • NDC: 71335-1847-5: 6 Tablets in a BOTTLE
  • NDC: 71335-1847-6: 10 Tablets in a BOTTLE
  • NDC: 71335-1847-7: 60 Tablets in a BOTTLE
  • NDC: 71335-1847-8: 90 Tablets in a BOTTLE
  • NDC: 71335-1847-9: 40 Tablets in a BOTTLE
  • NDC: 71335-1847-0: 24 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 325 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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