APHEN- acetaminophen tablet 
Asclemed USA, Inc.

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Drug Facts

Active Ingredient (in each tablet)

Acetaminophen 325mg

Purpose

Pain reliever/fever reducer


Uses

temporary relieves of minor aches and pains due to:

Warnings

Liver Warning: This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

  • with any other drug containing acetaminophen (prescription or non-prescription). 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 user has liver disease.

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin.

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days in adults
  • pain gets worse or lasts more than 5 days in children under 12 years
  • 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: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Adults and children 12 years of age and older: take 2 tablets every 4 to 6 hours while symptoms last. Do not take more than 10 tablets in 24 hours, unless directed by a doctor. Do not use for more than 10 days unless directed by a doctor.

Children 6 years to under 12 years: take 1 tablet every 4 to 6 hours while symptoms last. Do not take more than 5 tablets in 24 hours. Do not use for more than 5 days unless directed by a doctor.

Children under 6 years of age: ask a doctor.

Other information

Inactive ingredients

corn starch, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Principal Display Panel

Acetaminophen 325mg

Acetaminophen 325mg

APHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76420-372
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
Colorwhite (white) Scoreno score
ShapeROUND (Round) Size10mm
FlavorImprint Code AZ;010
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76420-372-15150 in 1 BOTTLE; Type 0: Not a Combination Product09/04/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01309/04/2020
Labeler - Asclemed USA, Inc. (059888437)

Revised: 10/2023
Document Id: 07ceca92-2158-8829-e063-6294a90a8c97
Set id: fe3c0a2b-316b-4620-b6bc-378dbaf7ed57
Version: 4
Effective Time: 20231016
 
Asclemed USA, Inc.