Home > Pill Identifier > Diphenhydramine Hydrochloride 25 MG Oral Tablet

Pill Identifier Information of Diphenhydramine Hydrochloride 25 MG Oral Tablet

Drug Information

Diphenhydramine Hydrochloride 25 MG Oral Tablet

Imprint: S4
Shape: C48345
Color: C48328
Ingredients: Diphenhydramine
Size: 10.00
Score: 1
Rxtty: SCD
Author: HIMPRIT PHARMACHEM PVT LTD
Inactive Ingredients: CELLULOSE, MICROCRYSTALLINE / SILICON DIOXIDE / ANHYDROUS DIBASIC CALCIUM PHOSPHATE / CROSCARMELLOSE SODIUM / MAGNESIUM STEARATE / POLYETHYLENE GLYCOL / POLYVINYL ALCOHOL / TITANIUM DIOXIDE / WATER / D&C RED NO. 27>

Complete Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Diphenhydramine HCl 25 mg

  • Purpose

    Antihistamine

  • Uses

    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
      • runny nose
      • sneezing
      • itchy, watery eyes
      • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing
  • Warnings

    Do not use with any other product containing diphenhydramine, even one used on skin

    Ask a doctor before use if you have

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

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

    When using this product

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

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

    Keep out of reach of children.

  • Directions

    adults and children 12 years and over1 to 2 tablets
    children 6 to under 12 years1 tablet
    children under 6 yearsdo not use this product in children under 6 years of age
  • PRINCIPAL DISPLAY PANEL - 25 mg Label

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

    Lot No:Jar No.:
    MFG. DATE:Quantity: 100,000 Tablets
    Exp. Date:NDC. No: 65437-036-10

    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:65437-036
    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
    ColorPINKScoreno score
    ShapeOVAL (CAPSULE-SHAPED) Size10mm
    FlavorImprint Code S4
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65437-036-051 in 1 DRUM
    150000 in 1 BAG
    2NDC:65437-036-071 in 1 DRUM
    275000 in 1 BAG
    3NDC:65437-036-101 in 1 DRUM
    3100000 in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34103/01/2010
    Labeler - HIMPRIT PHARMACHEM PVT LTD (917261992)