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 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 10135-152-01
ACETAMINOPHEN
500 MG

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10135-152
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 (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	ROUND	Size	12mm
Flavor		Imprint Code	MLX;152
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10135-152-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/1997

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	01/01/1997

Labeler - Marlex Pharmaceuticals Inc (782540215)