ACETAMINOPHEN- acetaminophen tablet 
Marlex Pharmaceuticals Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Acetaminophen

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:

* 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

Do not use

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

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:

Children under 12 years:

Other Information

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

Principal Display Panel
NDC 10135-152-01
ACETAMINOPHEN
500 MG

ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10135-152
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize12mm
FlavorImprint Code MLX;152
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10135-152-01100 in 1 BOTTLE; Type 0: Not a Combination Product01/01/1997
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34301/01/1997
Labeler - Marlex Pharmaceuticals Inc (782540215)

Revised: 2/2021
Document Id: ba71e396-f2c6-db89-e053-2995a90a1c1b
Set id: 79a727bb-3bae-4311-9827-939b92d9ba93
Version: 5
Effective Time: 20210203
 
Marlex Pharmaceuticals Inc