Label: DIPHENHYDRAMINE HYDROCHLORIDE tablet, film coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 3, 2010

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each caplet)

    Diphenhydramine HCl 25 mg

  • Purpose

    Nighttime sleep aid

  • Use

    relief of occasional sleeplessness

  • Warnings

    Do not use

    • in children under 12 years of age
    • with any other product containing diphenhydramine, even one used on skin

    Ask a doctor before use if you have

    • a breathing problem such as emphysema or chronic bronchitis
    • 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

    • avoid alcoholic drinks
    • drowsiness will occur
    • do not drive a motor vehicle or operate machinery

    Stop use and ask a doctor if

    • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

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

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Overdose warning: In case of overdose get medical help or contact a Poison Control Center right away.

    Directions

    adults and children 12 years and overtake 2 caplets at bedtime if needed or as directed by a doctor
    children under 12 yearsdo not use
  • Other information

    • each caplet contains: calcium 20 mg
    • store between 20-25°C (68-77°F)
    • do not use if carton is opened or blister unit is broken
    • see side panel for lot number and expiration date
  • Inactive ingredients

    carnauba wax, cellulose, croscarmellose sodium dibasic calcium phosphate, FD&C blue #1, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, titanium dioxide

  • PRINCIPAL DISPLAY PANEL - 25 mg Label

    DIPHENHYDRAMINE HCL TABLETS 25 mg BLUE
    Each Film coated Tablet Contains:
    DIPHENHYDRAMINE HCL 25 MG

    Lot No:Jar No.:
    MFG. DATE:Quantity: 100,000 Tablets
    Exp. Date:NDC. No: 65437-037-10

    WARNING :
    KEEP OUT OF THE REACH OF CHILDREN
    STORE CONTROLLED ROOM TEMPRATURE OF 59° –86°F (15° – 30°C)
    PROTECT FROM LIGHT, MOISTURE AND FREEZING
    THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.
    CONTENTS SHOULD BE APPROVED,REPACKAGED IMMEDIATELY AND LABELED IN STRICT
    CONFORMANCE WITH THE FDA AND REGULATIONS THEREUNDER

    MANUFACTURED BY:
    MANUFACTURED CODE No Guj/Drugs/G/1362
    LABELER CODE # 14803

    MANUFACTURED FOR:
    HIMPRIT PHARMACHEM PVT. LTD
    "LAKULISH", R.V.DESAI ROAD,
    NEXT TO NAVAPURA POLICE STATION
    BARODA, INDIA – 390 001

    CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"

    Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65437-037
    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
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeOVAL (CAPSULE-SHAPED) Size10mm
    FlavorImprint Code S5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65437-037-051 in 1 DRUM
    150000 in 1 BAG
    2NDC:65437-037-071 in 1 DRUM
    275000 in 1 BAG
    3NDC:65437-037-101 in 1 DRUM
    3100000 in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33803/01/2010
    Labeler - HIMPRIT PHARMACHEM PVT LTD (917261992)
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