Label: PREFERRED PLUS COMPLETE ALLERGY MEDICINE- 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 May 2, 2013

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  • Active ingredient (in each banded capsule)

    Diphenhydramine HCL 25 mg

  • Purpose

    Antihistamine

  • 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
    Temporarily relieves these symptoms due to the common cold
    • runny nose
    • sneezing
  • Warnings


    Do not use

    • With any other product containing Diphenhydramine even one used on skin

    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 pharmacist before use if you are

    taking sedatives or tranquilizers

    When using this product

    • marked drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • 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 the reach of children.

    In case of accidental overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • take every 4 to 6 hours
    • do not exceed 6 doses in 24 hours
    Adults and children 12 years of age and over

    1 to 2 capsules                                  

    Children 6 to under 12 years of

    age

    1 capsule

    Children under 6 years of ageask a doctor

  • Other information

    • Store at controlled room temperature 150-300C (590-860F)
    • Protect from excessive moisture
  • Inactive ingredients

    D & C Red #28, FD & C Blue #1, FD & C Red #40, Gelatin, Lactose Monohydrate, Magnesium Stearate, Silicon Dioxide, Sodium Lauryl Sulfate

  • Questions?

    Adverse drug event call: (866) 562-2756

  • Principal Display Panel

    Complete Allergy Medicine
    Antihistamine
    Diphenhydramine HCl 25mg
    For the temporary relief of:

    • itchy, watery eyes
    • runny nose,
    • itchy throat
    • sneezing

    Blocks Histamine
    *Compare to the Active Ingredient in Benadryl®.
    Safety Sealed Capsules
    *This product is not manufactured or distributed by McNeail Consumer Healthcare, owner of the registered trademark Benadryl®. All Preferred Plus Pharmacy are satisfaction guaranteed or your money back from retailer where purchased.
    Distributed By: Kinray, Inc.
    Whitestone, NY 11357
    ©2013 Kinray, Inc., All rights reserved, PREFERRED PLUS, PREFERRED PLUS ++++ and the PREFERRED PLUS logo are trademarks of Kinray, Inc. All other marks are property of their respective owners.
    Product Label

    Preferred Plus Complete Allergy Releif product label

  • INGREDIENTS AND APPEARANCE
    PREFERRED PLUS COMPLETE ALLERGY MEDICINE 
    diphenhydramine hydrochloride capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61715-055
    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
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code PH;014
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61715-055-511 in 1 CARTON
    1100 in 1 BOTTLE, PLASTIC
    2NDC:61715-055-242 in 1 CARTON
    212 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/07/2013
    Labeler - Kinray Inc. (012574513)
    Registrant - Pharbest Pharmaceuticals, Inc. (557054835)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharbest Pharmaceuticals, Inc.557054835manufacture(61715-055) , pack(61715-055) , label(61715-055)
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