VALUMEDS ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS LLC]

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  • VALUMEDS ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS LLC]

VALUMEDS ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS LLC]
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NDC 68210-1200-0
Set ID 39936c91-b395-4a96-b9b9-6e961fdcdbaf
Category HUMAN OTC DRUG LABEL
Packager Spirit Pharmaceuticals LLC
Generic Name
Product Class
Product Number
Application Number PART341
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Diphenhydramine HCl 25 mg

  • Purpose

    Antihistamine

  • Uses

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

    Do not use

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

    Ask a doctor before use if you have

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

    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
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children

    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. 1(800)222-1222

  • Directions

    • take every 4 to 6 hours or as directed by a doctor
    • do not take more than 6 times in 24 hours
    adults and children 12 years of age and over1 to 2 tablets
    children 6 to under 12 years of age1 tablet
    children under 6 years of agedo not use this product in children under 6 years of age

  • Other information

    • each tablet contains calcium 24 mg
    • store at controlled room temperature 15°-30°C (59°-86°F)
    • protect from moisture and light
  • Inactive ingredients

    colloidal silicon dioxide, croscarmellose sodium, D&C red No 27, dicalcium phosphate, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

  • Questions or comments?

    1-888-333-9792

  • SPL UNCLASSIFIED SECTION

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Benadryl®.

  • SPL UNCLASSIFIED SECTION

    Distributed By:

    Spirit Pharmaceuticals, LLC

    Ronkonkoma, NY 11779

    ORIG 06/17

  • Principal Display Panel - 600 ct Bottle Label

    VALUMEDS™

    Compare to the active ingredient in  Benadryl® Allergy Tablets*

    ALLERGY RELIEF 

    Antihistamine 
    Diphenhydramine HCl 25 mg

    For the temporary relief of:

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

    600 TABLETS

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    VALUMEDS ALLERGY RELIEF 
    diphenhydramine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-1200
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeCAPSULESize12mm
    FlavorImprint Code S4
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-1200-0600 in 1 BOTTLE; Type 0: Not a Combination Product04/17/2018
    2NDC:68210-1200-22 in 1 CARTON09/18/2020
    212 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/16/2018
    Labeler - Spirit Pharmaceuticals LLC (179621011)
    Establishment
    NameAddressID/FEIBusiness Operations
    ELYSIUM PHARMACEUTICALS LIMITED915664486manufacture(68210-1200)
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