Acetaminophen

Acetaminophen
SPL v5
SPL
SPL Set ID 79a727bb-3bae-4311-9827-939b92d9ba93
Route
ORAL
Published
Effective Date 2019-12-17
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 Potato Carboxymethylcellulose Sodium, Unspecified Form Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: MLX;152 Shape: round Color: white Size: 12 mm Score: 2
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 1997-01-01
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.
Active Ingredient

(in each tablet)            

Ace taminophen USP 500 mg

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

  • See end panel for lot number and expiration date.
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

Povidone, Pregelatinized Starch, Sodium Carboxymethyl Starch, Stearic Acid

Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Principal Display Panel

NDC 10 135-152-01

ACETAMINOPHEN

500 MG

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.

Ask A Doctor Before Use If You Have

liver disease.

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.
Active Ingredient

(in each tablet)            

Ace taminophen USP 500 mg

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

  • See end panel for lot number and expiration date.
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

Povidone, Pregelatinized Starch, Sodium Carboxymethyl Starch, Stearic Acid

Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Principal Display Panel

NDC 10 135-152-01

ACETAMINOPHEN

500 MG

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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

liver disease.

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:21.512189 · Updated: 2026-03-14T22:59:17.868516