ACETAMINOPHEN 325MG- acetaminophen tablet

Acetaminophen 325mg by

Drug Labeling and Warnings

Acetaminophen 325mg by is a Otc medication manufactured, distributed, or labeled by Marlex Pharmaceuticals Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient(in each tablet)

Acetaminophen USP 325 mg

Purpose

Pain Reliever/Fever Reducer

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

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

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.

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 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.

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.

Directions

Do not take more 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 6years:

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.

Other Information

• Store between 20-25 ˚C (68-77 ˚F).

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

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 325MG 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10135-828
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
POVIDONE K30 (UNII: U725QWY32X)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	C;19
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10135-828-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	02/01/2026

Labeler - Marlex Pharmaceuticals Inc (782540215)