EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET [GERI-CARE PHARMACEUTICAL CORP]

EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET [GERI-CARE PHARMACEUTICAL CORP]
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NDC 57896-200-01, 57896-200-05, 57896-200-06
Set ID 5f0fdbc8-bc1d-5df8-e053-2a91aa0ab27d
Category HUMAN OTC DRUG LABEL
Packager Geri-Care Pharmaceutical Corp
Generic Name
Product Class
Product Number
Application Number PART343
  • Active Ingredients

    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 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.

    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 tablets every 4-6 hours, as needed; not more than 8 tablets in 24 hours
    • children under 12 years: do not use
  • 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 propylparaben


  • PRINCIPAL DISPLAY PANEL

    HEALTH STAR

    THE SENSIBLE CHOICE FOR PRICE AND HEALTH

    NDC 57896-200-05

    Non-Aspirin

    Extra Strength

    PAIN RELIEF

    Acetaminophen Tablets

    Pain Reliever / Fever Reducer

    Compare to active ingredient in Extra Strength Tylenol Tablets*

    50 Tablets 500 mg each

    HST

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH PAIN RELIEF 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-200
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CROSPOVIDONE (UNII: 68401960MK)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Product Characteristics
    Colorwhite (WHITE) Scoreno score
    ShapeROUND (Round) Size12mm
    FlavorImprint Code M2A457344
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57896-200-01100 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2012
    2NDC:57896-200-0660 in 1 BOTTLE; Type 0: Not a Combination Product04/01/2014
    3NDC:57896-200-0550 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34301/01/1989
    Labeler - Geri-Care Pharmaceutical Corp (611196254)
    Registrant - Geri-Care Pharmaceutical Corp (611196254)
    Establishment
    NameAddressID/FEIBusiness Operations
    Geri-Care Pharmaceutical Corp611196254repack(57896-200)