EXTRA STRENGTH NIGHT TIME PAIN MEDICINE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [GERI-CARE PHARMACEUTICAL CORP]

EXTRA STRENGTH NIGHT TIME PAIN MEDICINE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [GERI-CARE PHARMACEUTICAL CORP]
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NDC 57896-224-01, 57896-224-05
Set ID 2b8f83ed-1ca9-49ac-9b2a-2609b68200f9
Category HUMAN OTC DRUG LABEL
Packager Geri-Care Pharmaceutical Corp
Generic Name
Product Class
Product Number
Application Number PART341
  • Active Ingredients

    Acetaminophen 500 mg

    Diphenhydramine HCI 25 mg

  • Purposes

    Pain Reliever

    Sleep aid

  • Uses

    for the temporary relief of occasional headaches and minor ache and pains along with accompanying sleeplessness

  • Warnings

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

    • more than 4,000 mg of acetaminophen in 24 hours
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product
    • Allergy alert: acetaminophen may cause severe skin reactions.

    Symptoms may include: • skin reddening • blisters • rash
    If a skin reaction occurs, stop use and seek medical help right away.

    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. • with any other product containing
    diphenhydramine, even one used on skin • in children under 12 years of age
    • if you have ever had an allergic reaction to this product or any of its ingredients

    Ask a doctor before use if you have • liver disease • a breathing problem such as emphysema or chronic bronchitis • glaucoma • difficulty urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if you are taking • the blood thinning drug warfarin

    • sedatives or tranquilizers

    When using this product • drowsiness will occur • do not drive a motor vehicle or operate machinery after use • avoid alcoholic drinks

    Stop use and ask a doctor if • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. • pain gets worse or lasts for more that 10 days • fever gets worse or lasts more than 3 days • new symptoms occur • redness or swelling is present.These may 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:
    In case of overdose, get medical help or contact a Poison
    Control Center right away. (1-800-222-1222). 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 (see overdose warning)

    Adults and Children 12 years and overTake 2 caplets at bedtime.
    Do not take more than 2 caplets of this product in 24 hours.
    Children under 12 yearsDo not use.

  • Other information

    • Tamper Evident: do not use if imprinted safety seal under cap is broken or missing.

    • store at room temperature

  • Inactive ingredients

    cellulose, croscarmellose sodium, FD&C blue #1 lake, hypromellose, PEG,
    povidone, silica, starch, stearic acid, titanium dioxide.

  • Questions or comments?

    1-800-540-3765

  • package Label

    1

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH NIGHT TIME PAIN MEDICINE 
    acetaminophen, diphenhydramine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-224
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE (UNII: FZ989GH94E)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorblueScoreno score
    ShapeCAPSULE (caplet) Size18mm
    FlavorImprint Code AZ267
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57896-224-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2012
    2NDC:57896-224-0550 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/01/1996
    Labeler - Geri-Care Pharmaceutical Corp (611196254)
    Registrant - Geri-Care Pharmaceutical Corp (611196254)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allegiant Health079501930manufacture(57896-224)