Label: ALLERGY RELIEF ANTIHISTAMINE- diphenhydramine hydrochloride tablet 

  • NDC Code(s): 49348-983-04, 49348-983-10
  • Packager: Mckesson (Sunmark)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/12

If you are a consumer or patient please visit this version.

  • Active ingredient (in each tablet)

    Diphenhydramine HCl 25 mg

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  • Purpose

    Antihistamine

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  • 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 of the common cold:

    • runny nose
    • sneezing 
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  • 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

    • glaucoma

    • 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

    • be careful when operating machinery or driving a motor vehicle

    • excitability may occur, especially in children

    If pregnant of 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)

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  • Directions

    • take every 4 to 6 hours
    • do not more than 6 doses in 24 hours
     adults and children 12 years of age and over  1 to 2 tablets 
     children 6 to under 12 years of age  1 tablet
    children under 6 years of age do not use this product in children under 6
     children under 4 years of age  do not use
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  • Other information

    • each tablet contains: calcium 25mg/ tablet
    • store at room temperature 15°-30°C (59°-86°F)
    • protect from light and moisture
    • do not use if imprinted safety seal under cap is broken or missing
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  • Inactive ingredients

    carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 Aluminum Lake, dibasic calcium phosphate dihydrate, hypromellose, *lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polysorbate 80, *polyvinyl alcohol, *purified water, *talc, and titanium dioxide

    * Contains one or more of these ingredients

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  • Questions or comments?

    Call toll free 1-877-753-3935 Monday- Friday 9AM- 5PM EST

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  • Principal Display Panel

    Allergy Relief

    Antihistamine

    For the temporary relief of:

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

    Diphenhydramine HCl 25 mg

    Compare to Benadryl® Allergy ultratab® Active Ingredient*

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, Division of McNeil-PPC, Inc., owner of the registered trademark Benadryl® Allergy Ultratab®

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

    THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

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  • Product Label

    Sunmark Allergy Relief

    Diphenhydramine HCl 25 mg

     

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  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF  ANTIHISTAMINE
    diphenhydramine hcl tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49348-983
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    CARNAUBA WAX  
    SILICON DIOXIDE  
    CROSCARMELLOSE SODIUM  
    D&C RED NO. 27  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE  
    HYPROMELLOSES  
    EGG PHOSPHOLIPIDS  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOL 400  
    POLYSORBATE 80  
    POLYVINYL ALCOHOL  
    WATER  
    TALC  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color PINK Score no score
    Shape CAPSULE Size 12mm
    Flavor Imprint Code T;61;V;25;S4
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49348-983-04 2 in 1 CARTON
    1 12 in 1 BLISTER PACK
    2 NDC:49348-983-10 1 in 1 BOX
    2 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part336 09/28/2011
    Labeler - Mckesson (Sunmark) (177667227)
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