Label: ACETAMINOPHEN ES- pharbetol tablet

  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated April 22, 2018

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  • Active ingredient (in each tablet)

    Acetaminophen 500mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    Temporarily relieves minor aches and pains due to:

    • headache
    • backache
    • minor pain of arthritis
    • toothache
    • muscular aches
    • menstrual cramps

    Temporarily reduces fever

  • Warnings

    Liver warning:

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

    more than 8 tablets 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
    • if you are allergic to acetaminophen or any of the inactive ingredients in this product


    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 and ask doctor before use 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 pregant or breast-feeding, ask doctor before use.

    Keep out of reach of children.

    Directions

    • do not take more than directed (see overdose warning).
    • Adult and Children 12 years and over: take 2 tablets, every 4 to 6 hours while symptoms last. Do not take more than 8 tablets in 24 hours. Do not take for more than 10 days unless directed by a doctor.
    • Children under 12 years: do not use adult extra strength product in children under 12 years of age; this will provide more than recommended dose (overdose) and may cause liver damage.

    Overdose warning:

    Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away.

  • Inactive ingredients

    Povidone, Pregelatinized corn starch, sodium starch glycolate, stearic acid.

  • Questions?

    Adverse drug event call: (866) 562-2756

  • PRINCIPAL DISPLAY PANEL

    apa

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN ES 
    pharbetol tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67046-028(NDC:16103-376)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE K30 (UNII: U725QWY32X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code PH044
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67046-028-3030 in 1 BLISTER PACK; Type 0: Not a Combination Product01/10/2006
    2NDC:67046-028-6060 in 1 BLISTER PACK; Type 0: Not a Combination Product01/10/2006
    3NDC:67046-028-6260 in 1 BLISTER PACK; Type 0: Not a Combination Product01/10/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34301/10/2006
    Labeler - Contract Pharmacy Services-PA (945429777)
    Establishment
    NameAddressID/FEIBusiness Operations
    Coupler Enterprises Inc.945429777repack(67046-028)