Acetaminophen by Marlex Pharmaceuticals Inc ACETAMINOPHEN tablet

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen 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 500 mg

Purpose

Pain Reliever/Fever Reducer

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

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

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.
• 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 (see overdosewarning)

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).

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

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10135-829
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

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

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	C;20
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10135-829-01	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)