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Pill Identifier Information of Diphenhydramine Hydrochloride 50 MG Oral Capsule

Drug Information

Diphenhydramine Hydrochloride 50 MG Oral Capsule

Imprint: cpc;836
Shape: C48336
Color: C48328
Ingredients: Diphenhydramine
Size: 4.00
Score: 1
Rxtty: SCD
Author: H.J. Harkins Company, Inc.
Inactive Ingredients: Gelatin / Lactose / Croscarmellose Sodium / Silicon Dioxide / FD&C RED NO. 40 / Magnesium Stearate>

Complete Information

  • 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