Acetaminophen 325mg

Acetaminophen 325mg
SPL v1
SPL
SPL Set ID 4a18168c-dd36-8280-e063-6394a90a7e10
Route
ORAL
Published
Effective Date 2026-02-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg)
Inactive Ingredients
Povidone K30 Starch, Corn Stearic Acid Sodium Starch Glycolate Type A Potato

Identifiers & Packaging

Pill Appearance
Imprint: C;19 Shape: round Color: white Size: 10 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

To reduce fever and for the temporary relief of minor aches and pains due to:

  • Headache
  • Backache
  • The common cold
  • Premenstrual and menstrual cramps
  • Temporarily reduces fever
  • Muscular ache
  • Minor pain of arthritis
  • Toothache
Section 42229-5

Drug Facts

Warnings

Liver warning : this product contains acetaminophen.

Severe liver damage may occur if

  • adult takes more than 12 tablets in 24 hours, which is the maximum daily amount
  • child takes more than 5 doeses in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product
Directions

Do not take m ore than directed

Adults and Children 12 years and over:

  • Take 2 tablets every 4 to 6 hours while symptoms last.
  • Do not take more than 12 tablets in 24 hours

Children 6-11 years:

  • Take 1 tablet every 4 to 6 hours while symptoms last.
  • Do not take more than 5 tablets in 24 hours.

Children under 6 years:

Do not use this adult regular strength product in children under 6 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.

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

Acetaminophen USP 325 mg

Ask A Doctor Or P

if you are taking the blood thinning drug warfarin.

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 10135-0828-01

Acetaminophen

325 mg

100 TABLETS

Stop Use and Ask A Doctor If
  • Pain gets worse or lasts more than 10 days in adults and children.
  • Pain gets worse or lasts more than 5 days in children under 12 years.
  • 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

To reduce fever and for the temporary relief of minor aches and pains due to:

  • Headache
  • Backache
  • The common cold
  • Premenstrual and menstrual cramps
  • Temporarily reduces fever
  • Muscular ache
  • Minor pain of arthritis
  • Toothache
Section 42229-5 (42229-5)

Drug Facts

Purpose

Pain Reliever/ Fever Reducer

Warnings

Liver warning : this product contains acetaminophen.

Severe liver damage may occur if

  • adult takes more than 12 tablets in 24 hours, which is the maximum daily amount
  • child takes more than 5 doeses in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product
Directions

Do not take m ore than directed

Adults and Children 12 years and over:

  • Take 2 tablets every 4 to 6 hours while symptoms last.
  • Do not take more than 12 tablets in 24 hours

Children 6-11 years:

  • Take 1 tablet every 4 to 6 hours while symptoms last.
  • Do not take more than 5 tablets in 24 hours.

Children under 6 years:

Do not use this adult regular strength product in children under 6 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.

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

Acetaminophen USP 325 mg

Ask A Doctor Or P (Ask a doctor or p)

if you are taking the blood thinning drug warfarin.

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 (PRINCIPAL DISPLAY PANEL)

NDC 10135-0828-01

Acetaminophen

325 mg

100 TABLETS

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • Pain gets worse or lasts more than 10 days in adults and children.
  • Pain gets worse or lasts more than 5 days in children under 12 years.
  • 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

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