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 57896-221-01, 57896-221-05, 57896-221-10, 57896-221-25
Set ID ae00015d-5e5f-4099-ba03-b20bf45ed374
Category HUMAN OTC DRUG LABEL
Packager Geri-Care Pharmaceutical Corp
Generic Name
Product Class
Product Number
Application Number PART343
  • Active ingredient

    Acetaminophen 500 mg

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  • Purpose

    Pain Reliever/Fever Reducer

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  • Uses

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

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  • 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
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  • 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

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  • Package label

    GERICARE

    NDC 57896-221-01

    Non-Aspirin

    Extra Strength

    PAIN RELIEF

    Acetaminophen Caplets

    Pain Reliever / Fever Reducer

    Compare to active ingredients in Extra Strength Tylenol Caplets*

    PACKAGE NOT CHILD RESISTANT

    100 Caplets 500 mg each

    gc

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  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH PAIN RELIEF 
    acetaminophen tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:57896-221
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color white (WHITE) Score no score
    Shape CAPSULE (Capsule) Size 15mm
    Flavor Imprint Code M2A457344
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57896-221-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/01/2011
    2 NDC:57896-221-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2011
    3 NDC:57896-221-05 50 in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2013
    4 NDC:57896-221-25 250 in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 01/01/1989
    Labeler - Geri-Care Pharmaceutical Corp (611196254)
    Registrant - Geri-Care Pharmaceutical Corp (611196254)
    Establishment
    Name Address ID/FEI Business Operations
    Geri-Care Pharmaceutical Corp 611196254 repack(57896-221)
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