GERI-DRYL ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]

GERI-DRYL ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]
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NDC 57896-681-01, 57896-681-10, 57896-681-24
Set ID 9d3419b6-9845-4b6c-a359-05497daacfa3
Category HUMAN OTC DRUG LABEL
Packager Geri-Care Pharmaceutical Corp
Generic Name
Product Class
Product Number
Application Number PART336
  • Active ingredient (in each tablet)

    Diphenhydramine Hydrochloride 25mg

  • Purpose

    Antihistamine

  • Uses

    • temporarily relieves these symptoms due to hay fever and other upper respiratory allergies:
    • runny nose

    • sneezing

    • itching of the nose and throat
    • itchy, watery eyes
  • Warnings

    Do not use

    • to make a child sleepy
    • with any other product containing diphenhydramine, including one used on skin

    Ask a doctor before use if you have

    • a breathing problem such as chronic bronchitis or emphysema
    • trouble urinating due to an enlarged prostate gland
    • glaucoma

    Ask a doctor or pharmacist before use if you are

    • taking sedatives or tranquilizers

    When using this product

    • excitability may occur, especially in children
    • marked drowsiness may occur
    • be careful when driving a motor vehicle or operating machinery
    • avoid alcoholic drinks
    • alcohol, sedatives and tranquilizers may increase drowsiness

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • do not exceed recommended dose
    • adults and children 12 years and over, take 1 to 2 tablets every 4-6 hours, as needed; not more than 12 tablets in 24 hours, or as directed by a doctor
    • children under 12 years: consult a doctor
  • Other information

    • each tablet contains: calcium 25mg
    • store at room temperature 15⁰C - 30⁰C (59⁰F - 86⁰F)
    • for institutional use only
  • Inactive ingredients

    cellulose, croscarmellose sodium, D&C red #27 lake, dicalcium phosphate, hypromellose, magnesium stearate, PEG, polysorbate 80, silica, titanium dioxide, wax.

  • package label

    New! Ultra Small Tablets
    NDC 57896-681-01

    GERICARE
    GERI-DRYL
    (ALLERGY RELIEF)
    Diphenhydramine HCl
    Antihistamine
    Compare to active ingredient in Benadryl Ultratabs
    PACKAGE NOT CHILD RESISTANT
    100 Tablets
    25 mg each

    Geri-dryl allergy relief label

  • INGREDIENTS AND APPEARANCE
    GERI-DRYL ALLERGY RELIEF 
    diphenhydramine hcl tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-681
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeCAPSULESize11mm
    FlavorImprint Code T;061
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57896-681-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/01/2012
    2NDC:57896-681-101000 in 1 BOTTLE; Type 0: Not a Combination Product11/01/2012
    3NDC:57896-681-241 in 1 CARTON09/01/2011
    324 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33609/01/2011
    Labeler - Geri-Care Pharmaceutical Corp (611196254)
    Registrant - Geri-Care Pharmaceutical Corp (611196254)
    Establishment
    NameAddressID/FEIBusiness Operations
    Geri-Care Pharmaceutical Corp611196254repack(57896-681)