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Pill Identifier Information of Diphenhydramine Hydrochloride 50 MG Oral Capsule

Drug Information

Diphenhydramine Hydrochloride 50 MG Oral Capsule

Imprint: 293
Shape: C48345
Color: C48333
Ingredients: Diphenhydramine
Size: 18.00
Score: 1
Rxtty: SCD
Author: SPIRIT PHARMACEUTICALS,LLC
Inactive Ingredients: POLYETHYLENE GLYCOL 400 / PROPYLENE GLYCOL / GELATIN / SORBITOL / WATER / FD&C BLUE NO. 1>

Complete Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients (in each LiquiCap)

    Diphenhydramine HCl 50 mg

  • Purpose

    Nighttime Sleep aid

  • Uses

    For relief occasional sleeplessness

  • Warnings

    Do not use
    • for 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
    • Glaucoma
    • trouble urinating due to enlarged postage gland
    • a breathing problem such as emphysema or chronic bronchitis

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

    When using this product avoid alcoholic drinks

    Stop use and ask 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.

    In case of overdose,get medical help or contact a poison control center right away.

  • Direction

    adults and children 12 years of age and older -1 softgel (50mg) at bedtime if needed; or as directed by doctor

  • Inactive ingredients

    PEG – 400, Propylene Glycol USP , Gelatin , Sorbitol, FD & C Blue No.1 IH, Purified water

  • PRINCIPAL DISPLAY PANEL - 50 mg Shipper Label

    Diphenhydramine Hydrochloride Soft Gelatin Capsules

    Each soft gelatin capsule contains:
    Diphenhydramine Hydrochloride USP 50 mg

    LOT NO :

    MFG DATE :

    EXP. DATE :

    NDC NO : 68210-1510-4

    QUANTITY : 1000 × 4 Capsules

    GROSS WT. :

    WARNING:
    KEEP OUT OF REACH OF CHILDREN

    STORE AT CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C)
    PROTECT FROM LIGHT, MOISTURE AND FREEZING

    THIS BULK SHIPMENT IS INTENDED FOR FURTHER PACKAGING PROCESS ONLY.
    CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT
    CONFORMANCE WITH THE FD & C ACT AND REGULATIONS THEREUNDER.

    MANUFACTURED BY:
    Marksans Pharma Ltd
    VERNA, GOA-403722,
    INDIA.
    CODE : GO/DRUGS/515

    MANUFACTURED FOR:
    SPIRIT PHARMACEUTICALS LLC
    225 LINCOLN HWY, STE 205
    FAIRLESS HILLS, PA 19030
    PH.# 215 943 4000
    FAX.# 215 943 4039

    CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"

    OLIL058

    PRINCIPAL DISPLAY PANEL - 50 mg Shipper Label
  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-1510
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GELATIN (UNII: 2G86QN327L)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeOVALSize18mm
    FlavorImprint Code 293
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-1510-41 in 1 DRUM
    14000 in 1 BAG
    2NDC:68210-1510-61 in 1 DRUM
    26000 in 1 BAG
    3NDC:68210-1510-81 in 1 DRUM
    38000 in 1 BAG
    4NDC:68210-1510-11 in 1 DRUM
    410000 in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33806/01/2010
    Labeler - SPIRIT PHARMACEUTICALS,LLC (179621011)
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