Label: DIPHENHYDRAMINE- diphenhydramine hydrochloride capsule

  • Category: HUMAN OTC DRUG LABEL

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 April 18, 2012

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  • Active ingredient

    Diphenhydramine Hydrochloride 50mg

  • Purpose

    Antihistamine

  • Use

    Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies and common cold, sneezing, runny nose, itchy, watery eyes, itchy throat and nose.

  • Warning

    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 pharamcist before use if you are

    taking tranquilizers or sedatives.

  • When using this product

    you may get drowsy; avoid alcoholic drinks. Alcohol, sedatives and tranquilizers may increase drowsiness. Be careful when driving a motor vehicle or operating machinery. Excitability may occur, especially in children. Do not use any other products containing diphenhydramine.

  • Pregnancy/breast-feeding warning

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

  • Keep out of reach of children

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

  • Directions

    Adults and children 12 years and over: take 25 to 50 mg (1 to 2 capsule) every 4 to 6 hours; not more than 12 capsules in 24 hours.

    Children 6 years to 12 years of age: take 25 mg (1 capsule) every 4 to 6 hours; not more than 6 capsules in 24 hours.

    Children under 6 years of age: ask a doctor.

  • Other information

    Store at controlled room temperature 59-86 degrees F.

  • Inactive ingredients

    Lactose, starch, gelatin with bisulfites and artificial colors.

  • Questions?

    Adverse drug event call: (800) 616-2471

    Repacked by:

    H.J. Harkins Company, Inc.

    Grover Beach, CA 93433

  • PRINCIPAL DISPLAY PANEL

    Label

    Label

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE  
    diphenhydramine hydrochloride capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52959-053(NDC:0904-5307)
    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
    Gelatin (UNII: 2G86QN327L)  
    Lactose (UNII: J2B2A4N98G)  
    Croscarmellose Sodium (UNII: M28OL1HH48)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeCAPSULESize4mm
    FlavorImprint Code cpc;836
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52959-053-0606 in 1 BOTTLE
    2NDC:52959-053-1212 in 1 BOTTLE
    3NDC:52959-053-1515 in 1 BOTTLE
    4NDC:52959-053-2020 in 1 BOTTLE
    5NDC:52959-053-1010 in 1 BOTTLE
    6NDC:52959-053-3030 in 1 BOTTLE
    7NDC:52959-053-5252 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34808/17/2011
    Labeler - H.J. Harkins Company, Inc. (147681894)
    Registrant - H.J. Harkins Company, Inc. (147681894)
    Establishment
    NameAddressID/FEIBusiness Operations
    H.J. Harkins Company, Inc.147681894repack, relabel
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