Acetaminophen 500mg

Acetaminophen 500mg
SPL v1
SPL
SPL Set ID 4a183b7d-3a1e-5557-e063-6294a90a5493
Route
ORAL
Published
Effective Date 2026-02-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg)
Inactive Ingredients
Povidone K30 Sodium Starch Glycolate Type A Potato Starch, Corn Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: C;20 Shape: round Color: white Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-02-01
Description

Drug Facts

Purpose

Pain Reliever/Fever Reducer

Medication Information

Purpose

Pain Reliever/Fever Reducer

Description

Drug Facts

Uses

Temporary relieves minor aches and pains due to:

  • The common cold • Headache
  • Backache • Minor pain of arthritis
  • Toothache • Muscular aches
  • Premenstrual and menstrual cramps

* Temporarily reduces fever

Section 42229-5

Drug Facts

Warnings

Liver warning : this product contains acetaminophen. The maximum daily dose of this product is 6 tablets (3,000 mg) in 24 hours. Severe liver damage may occur if you take

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

Do not take more than directed (see overdose warning)

Adults and Children 12 years and over:

  • Take 2 tablets every 6 hours while symptoms last.
  • Do not take more than 6 tablets in 24 hours, unless directed by a doctor.
  • Do not use for more than 10 days unless directed by a doctor.

Children under 12 years:

  • ask a doctor.
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.

Active Ingredient

(in each tablet)

Ace taminophen USP 500 mg

Other Information
  • Store between 20-25 ˚C (68-77 ˚F).
Overdose Warning:

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222).

Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Inactive Ingredients

Pregelatinized Starch, Povidone K 30,Sodium starch Glycolate, Stearic Acid.

Manufactured for/ Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Rev. 01/26 AA

Principal Display Panel

NDC 10135-0829-01

ACETAMINOPHEN

500 MG

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 symptoms 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.

Keep Out of Reach of Children.

Structured Label Content

Uses

Temporary relieves minor aches and pains due to:

  • The common cold • Headache
  • Backache • Minor pain of arthritis
  • Toothache • Muscular aches
  • Premenstrual and menstrual cramps

* Temporarily reduces fever

Section 42229-5 (42229-5)

Drug Facts

Purpose

Pain Reliever/Fever Reducer

Warnings

Liver warning : this product contains acetaminophen. The maximum daily dose of this product is 6 tablets (3,000 mg) in 24 hours. Severe liver damage may occur if you take

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

Do not take more than directed (see overdose warning)

Adults and Children 12 years and over:

  • Take 2 tablets every 6 hours while symptoms last.
  • Do not take more than 6 tablets in 24 hours, unless directed by a doctor.
  • Do not use for more than 10 days unless directed by a doctor.

Children under 12 years:

  • ask a doctor.
Do Not Use (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 (Ask a doctor)

before use if you have liver disease.

Active Ingredient

(in each tablet)

Ace taminophen USP 500 mg

Other Information
  • Store between 20-25 ˚C (68-77 ˚F).
Overdose Warning: (Overdose warning:)

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222).

Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Inactive Ingredients

Pregelatinized Starch, Povidone K 30,Sodium starch Glycolate, Stearic Acid.

Manufactured for/ Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Rev. 01/26 AA

Principal Display Panel

NDC 10135-0829-01

ACETAMINOPHEN

500 MG

Ask A Doctor Or Pharmacist (Ask a doctor or pharmacist)

before use if you are taking the blood thinning drug warfarin.

Stop Use and Ask A Doctor If (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 symptoms occur.
  • Redness or swelling is present.

These could be signs of a serious condition.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:32.249919 · Updated: 2026-03-14T23:12:47.494493