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

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 10 tablets (3,250 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.

Drug Facts (continued)

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 12 tablets in 24 hours, unless directed by a doctor.
  
• Do not use for more than 10 days unless directed by a doctor.

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:

• 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: 10135-0123-01
Acetaminophen
325 mg
100 TABLETS

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 325MG 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10135-123
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, UNSPECIFIED (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	8mm
Flavor		Imprint Code	MLX123
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10135-123-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	04/01/2018

Labeler - Marlex Pharmaceuticals Inc (782540215)