Label: DIPHENHYDRAMINE- diphenhydramine hydrochloride capsule

  • 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 August 14, 2014

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  • ACTIVE INGREDIENT

    Active Ingredient (each banded capsule contains)
    Diphenhydramine HCL 50 mg
  • PURPOSE

    Purpose
    Antihistaminne
  • INDICATIONS & USAGE

    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
  • WARNINGS

    Ask a doctor before use if you have

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

    Do not use to make a child sleepy

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

  • WHEN USING

    When using this product

    • marked drowsiness may occur
    • 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
  • PREGNANCY OR BREAST FEEDING

    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.

  • DOSAGE & ADMINISTRATION

    Directions:

    • Take every 4 to 6 hours.
    • Do not take more than 6 doses in any 24-hour period.
    Adults and Children 12 years of age and over1 to 2 capsules
    Children 6 to under 12 years of age1 capsule
    Children under 6 years of ageDo not use
  • STORAGE AND HANDLING

    Other information

    • Store between 15-30 degree Celsius (59-86 degree Fahrenheit)
    • Protect from moisture
  • INACTIVE INGREDIENT

    D&C red 28, gelatin, lactose monohydrate, magnesium stearate, maize starch, polysorbate tween 80, silica gel.

  • HOW SUPPLIED

    Pack Size: 50 Capsules in a Bottle
    Batch No.:
    Mfg. Date:
    Exp. Date:

  • OTHER SAFETY INFORMATION

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING OR IF RED BAND AROUND CAPSULE IS BROKEN OR MISSING.

  • PRINCIPAL DISPLAY PANEL

    NDC 58599-004-90
    NDC 58599-004-25
    NDC 58599-004-29
    NDC 58599-004-35

    Manufactured By: PURINEPHARMA LLC
    5 County Route 42
    Massena, NY – 13662
    www.purinepharma.com

    50000 Capsules
    Carton for 50 Capsules in a Bottle
  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE 
    diphenhydramine hydrochloride capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58599-004
    Route of AdministrationORAL, Type 0: Not a Combination Product
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    GELATIN (UNII: 2G86QN327L)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Product Characteristics
    ColorPINK (PINK CAP and PINK BODY) Score2 pieces
    ShapeCAPSULESize14mm
    FlavorImprint Code DH;50
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58599-004-9050000 in 1 BOX
    2NDC:58599-004-251 in 1 CARTON
    250 in 1 BOTTLE
    3NDC:58599-004-291 in 1 CARTON
    3100 in 1 BOTTLE
    4NDC:58599-004-351 in 1 CARTON
    41000 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/31/2014
    Labeler - PURINEPHARMA LLC (019950491)
    Registrant - PURINEPHARMA LLC (019950491)
    Establishment
    NameAddressID/FEIBusiness Operations
    PURINEPHARMA LLC019950491manufacture(58599-004)
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