ACETAMINOPHEN 325MG- 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 325mg

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:

* 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

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:

Children 6-11 years:

Children under 6 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 10135-0123-01
Acetaminophen
325 mg

100 TABLETS

PRINCIPAL DISPLAY PANEL
NDC 10135-0123-01
Acetaminophen
325 mg
100 TABLETS

PRINCIPAL DISPLAY PANEL
NDC 10135-0123-01
Acetaminophen
325 mg
100 TABLETS

ACETAMINOPHEN 325MG 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10135-123
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize8mm
FlavorImprint Code MLX123
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10135-123-01100 in 1 BOTTLE; Type 0: Not a Combination Product04/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/01/2018
Labeler - Marlex Pharmaceuticals Inc (782540215)

Revised: 2/2021
Document Id: ba72bba7-176e-4f83-e053-2995a90a86ec
Set id: c26f1872-ebff-4164-bf64-4272df43a2db
Version: 3
Effective Time: 20210203
 
Marlex Pharmaceuticals Inc