Label: APHEN- acetaminophen tablet

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 16, 2023

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  • Active Ingredient (in each tablet)

    Acetaminophen 325mg

  • Purpose

    Pain reliever/fever reducer


  • Uses

    temporary relieves of minor aches and pains due to:

    • headache
    • muscular aches
    • backache
    • minor pain of arthritis
    • the common cold
    • toothache
    • 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 for adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if

    • adult takes more than 4,000mg of acetaminophen in 24 hours
    • child takes more than 5 doses in 24 hours, which is the maximum daily amount
    • taken with other drugs containing acetaminophen
    • adult has 3 or more alcoholic drinks every day while using this product

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

    • skin reddening
    • blisters
    • rash 

    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

    • store at room temperature 20°–25°C (68°– 77°F)
    • do not use if imprinted safety seal under cap is broken or missing
    • you may report side effects to (310) 320-0100
  • Inactive ingredients

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

  • Principal Display Panel

    Acetaminophen 325mg

    Acetaminophen 325mg

  • INGREDIENTS AND APPEARANCE
    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)
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