Label: EXTRA STRENGTH PAIN RELIEF- acetaminophen tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 18, 2023

If you are a consumer or patient please visit this version.

  • Active ingredient

    Acetaminophen 500 mg

  • Purpose

    Pain Reliever/Fever Reducer

  • Uses

    • temporarily relieves minor aches and pains
    • temporarily reduces fever
  • Warnings

    Liver warning:

    This product contains acetaminophen. Severe liver damage may occur if you take

    • more than 8 caplets in 24 hours, which is the maximum daily amount
    • 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.

    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 symptom 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.
    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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

    Keep out of reach of children.

  • Directions

    • do not take more than directed
    • adults and children 12 years and over: take 1-2 caplets every 4-6 hours, as needed; not more than 8 caplets in 24 hours
    • children under 12 years: ask a doctor
  • Other Information

    • TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.
    • store at 20⁰C-25⁰C (68⁰F-77⁰F)
    • for institutional use only

    Inactive ingredients

    povidone, sodium starch glycolate, starch, stearic acid. May also contain: crospovidone, methylparaben and probylparaben

  • Package label

    ACET

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH PAIN RELIEF 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60760-222(NDC:57896-221)
    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)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CROSPOVIDONE (UNII: 68401960MK)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Product Characteristics
    Colorwhite (WHITE) Scoreno score
    ShapeCAPSULE (Capsule) Size15mm
    FlavorImprint Code M2A457344
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60760-222-4040 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/16/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01302/16/2018
    Labeler - St. Mary's Medical Park Pharmacy (063050751)
    Establishment
    NameAddressID/FEIBusiness Operations
    St. Mary's Medical Park Pharmacy063050751relabel(60760-222) , repack(60760-222)