Label: DIPHENHYDRAMINE HCL capsule, liquid filled

  • 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 December 13, 2012

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  • Drug Facts

  • Active Ingredient in each Softgel

    Diphenhydramine HCl 25 mg

  • Purpose

    Nighttime sleep-aid

  • Keep out of reach of Children

  • Uses

    • for relief of occassional sleeplessness
    • reduces time to fall asleep if you have difficulty falling asleep
  • Warnings

    Do not use

    • for children under 12 years of age
    • with any other product containing diphenhydramine, even one used on skin
    • with other drugs that causes drowsiness such as antihistamines & nighttime cold/flu products
  • Directions

    Take only one dose per day (24 hours) - see Overdose warning

    adults & children 12 yrs & over One dose = Two 25 mg Softgels (50 mg) at bedtime if needed or as directed by a doctor

  • Other Information

    • store at 20-25˚C (68-77˚F)
    • avoid excessive heat above 40˚C (104˚F) and high humidity
    • protect from light
  • Inactive Ingredients

    FD&C blue#1, FD&C red#40, gelatin, glycerin, methylparaben, polyethylene glycol, propylparaben, purified water, sorbitol, titanium dioxide

  • Principal Display Panel

    Diphenhydramine Hydrochloride Capsules, USP 25 mg

    bag-label

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HCL 
    diphenhydramine hcl capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48769-060
    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
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpurpleScoreno score
    ShapecapsuleSize7mm
    FlavorImprint Code R60
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48769-060-995000 in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33801/01/2013
    Labeler - Softech Pharma Pvt. Ltd (677111277)
    Establishment
    NameAddressID/FEIBusiness Operations
    Softech Pharma Pvt. Ltd677111277manufacture(48769-060)
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