Label: GOOD NEIGHBOR PHARMACY ALLERGY- 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 March 13, 2012

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  • Active ingredient (in each capsule)

    Diphenhydramine hydrochloride 25 mg

  • Purpose

    Antihistamine

  • Uses

    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itchy nose or throat
    • temporarily relieves these symptoms of the common cold:
    • runny nose
    • sneezing
  • Warnings

    Do not use

    • with any other product containing diphenhydramine, even one used on skin
    • to make a child sleepy

    Ask a doctor before use if you have

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

    Ask a doctor or pharmacist before use if you are

    taking tranquilizers or sedatives

    When using this product

    • excitability may occur, especially in children
    • marked drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery

    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.

  • Directions

    • take every 4 to 6 hours, not more than 6 doses in 24 hours
    adults and children 12 years of age and over 1 or 2 capsules
    children 6 to under 12 years of age 1 capsule
    children 4 to under 6 years of age do not use unless directed by a doctor
    children under 4 years of age do not use
  • Other information

    • store at room temperature (59°-86°F)
    • protect from moisture
  • Inactive ingredients

    benzyl alcohol, butylparaben, D&C red no. 28, D&C yellow no. 10, edetate calcium disodium, edible ink, FD&C blue no. 1, FD&C blue no. 2, FD&C red no. 40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, silicon dioxide, sodium lauryl sulfate, sodium propionate

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    Compare to active ingredient in Benadryl® Allergy Kapseals®

    See New Warning and Dosing Directions

    Allergy

    Diphenhydramine HCl

    Antihistamine

    Easy to Swallow

    For Allergy Relief

    Sneezing

    Itchy, Watery Eyes

    Runny Nose

    Itchy Throat

    Diphenhydramine HCl (Allergy) 25mg

  • INGREDIENTS AND APPEARANCE
    GOOD NEIGHBOR PHARMACY ALLERGY 
    diphenhydramine hydrochloride capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42254-178(NDC:24385-462)
    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
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM PROPIONATE (UNII: DK6Y9P42IN)  
    Product Characteristics
    ColorPINK (clear) , WHITE (clear) , RED (band) Scoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code L462
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42254-178-242 in 1 CARTON
    112 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/15/1989
    Labeler - Rebel Distributors Corp (118802834)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rebel Distributors Corp118802834RELABEL, REPACK
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