Label: CHILDRENS ALLERGY- diphenhydramine hydrochloride tablet

  • 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 October 4, 2010

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  • Active ingredient (in each tablet)

    Diphenhydramine HCl 12.5mg

  • Purpose

    Antihistamine

  • INDICATIONS & USAGE

    Uses For the temporary relief of runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies or allergic rhinitis.

  • 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

    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • difficulty in urination due to an enlargement of prostate gland

    Ask a doctor before use if you are taking sedatives or tranquilizers


    When using this product

    • Avoid alcoholic beverages
    • Marked drowsiness may occur
    • Alcohol, sedatives and tranquilizers may increase the drowsiness effect
    • Excitability may occur, especially in children
    • 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 Center right away (1-800-222-1222).

  • Directions

    • Take every 4 to 6 hours
    • Do not take more than 6 times in 24 hours
    Adults and Children 12 years of age and over2 to 4 tablets
    Children 6 to under 12 years of age1 to 2 tablets
    Children under 6 years of ageConsult a doctor
    Children under 4 years of ageDo not use
  • Other Information

    • Do not use if carton is opened or blister unit is broken
    • Store between 20-25°C (68-77°F).  Avoid high humidity. Protect from light.
    •  See end panel for lot number and expiration date.
  • Inactive ingredients

    aqueous ethyl cellulose dispersion, citric acid, crospovidone, D and C Red # 7 calcium lake, dibasic calcium phosphate, flavor, magnesium stearate, maltodextrin, mannitol, methacrylic acid copolymer, microcrystalline cellulose,  modified food starch, silicon dioxide, sodium lauryl sulfate, sodium starch glycolate, sucralose, talc, triacetin

  • Principal Display Panel

    Capricorn Pharma

    ORIGINAL DEVELOPERS AND MANUFACTURERS

    NDC 66007-212-02

    COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN'S BENADRYL ALLERGY FASTMELT

    Children's Allergy

    Diphenhydramine HCl 12.5mg

    ANTIHISTAMINE

    Temporarily Relieves:

    • Sneezing
    • Itchy, Watery Eyes
    • Runny Nose
    • Itchy Throat
    Cherry Flavor

    RAPIDMELT
    18 Fast Dissolving Tablets

    Diphenhydramine HCl Antihistamine carton

  • INGREDIENTS AND APPEARANCE
    CHILDRENS ALLERGY 
    diphenhydramine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66007-212
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLCELLULOSE (UNII: 7Z8S9VYZ4B)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CROSPOVIDONE (UNII: 68401960MK)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MANNITOL (UNII: 3OWL53L36A)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIACETIN (UNII: XHX3C3X673)  
    AMMONIA (UNII: 5138Q19F1X)  
    CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85)  
    OLEIC ACID (UNII: 2UMI9U37CP)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeROUNDSize12mm
    FlavorCHERRYImprint Code None
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66007-212-023 in 1 CARTON
    1NDC:66007-212-016 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/29/2010
    Labeler - Capricorn Pharma Inc. (041704524)
    Registrant - Capricorn Pharma Inc. (041704524)
    Establishment
    NameAddressID/FEIBusiness Operations
    Capricorn Pharma Inc.041704524manufacture
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