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
Purpose

Pain Reliever/Fever Reducer

Description

Drug Facts

Medication Information

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
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

Purpose

Pain Reliever/Fever Reducer

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

  • See end panel for lot number and expiration date.
Inactive Ingredients

Povidone, Pregelatinized Starch, Sodium Carboxymethyl Starch, Stearic Acid

Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Description

Drug Facts

Principal Display Panel

NDC 10 135-152-01

ACETAMINOPHEN

500 MG

Section 42229-5

Drug Facts

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

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.

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

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
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

Purpose

Pain Reliever/Fever Reducer

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

  • See end panel for lot number and expiration date.
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

Section 42229-5 (42229-5)

Drug Facts

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

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.

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

All Sections (JSON)

Additional Information

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