EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, GELATIN COATED [GERI-CARE PHARMACEUTICAL CORP]

EXTRA STRENGTH PAIN RELIEF (ACETAMINOPHEN) CAPSULE, GELATIN COATED [GERI-CARE PHARMACEUTICAL CORP]
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NDC 57896-251-01
Set ID e65dbd01-2d5e-4067-ad98-98d879cfb5ee
Category HUMAN OTC DRUG LABEL
Packager Geri-Care Pharmaceutical Corp
Generic Name
Product Class
Product Number
Application Number PART343
  • Active ingredient (in each gelcap)

    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 gelcaps 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.

    Keep out of reach of children

    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.

  • Directions

    • Do not take more than directed
    • Adults and children 12 years and over: take 2 gelcaps every 4-6 hours, as needed. Do not take more than 8 gelcaps 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)
    • avoid high humidity

  • Inactive Ingredients

    Croscarmellose Sodium, D and C Red 33, FD and C Blue 1, FD and C Red 40, Gelatin, Hydroxypropyl Cellulose, Hypromellose, Iron Oxide, PEG, Povidone, Propylene Glycol, Shellac Glaze, Starch, Stearic Acid, Titanium Dioxide.

  • Package label


    Gericare

    NDC 57896-251-01

    Non-aspirin

    Extra Strength

    PAIN RELIEF

    Pain Reliever / Fever Reducer

    Compare to active ingredient in Tylenol Extra Strength Rapid Release gels

    ACETAMINOPHEN

    Rapid Release Gels

    100 Gelcaps

    500 mg each

    Rapid release gelcaps label

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH PAIN RELIEF 
    acetaminophen capsule, gelatin coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-251
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SHELLAC (UNII: 46N107B71O)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    Colorred (red, gray and blue) Scoreno score
    ShapeCAPSULE (Gelcap) Size19mm
    FlavorImprint Code L5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57896-251-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34306/01/2007
    Labeler - Geri-Care Pharmaceutical Corp (611196254)
    Registrant - Geri-Care Pharmaceutical Corp (611196254)