Label: ALLERGY RELIEF ANTIHISTAMINE- diphenhydramine hcl tablet

  • NDC Code(s): 49348-983-04, 49348-983-10
  • Packager: Strategic Sourcing Services LLC
  • 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 18, 2019

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

  • 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
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat

    temporarily relieves these symptoms of 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

    • 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)

  • 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 agedo not use this product in children under 6
     children under 4 years of age do not use
  • 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
  • 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

  • Questions or comments?

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

  • 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.

  • Product Label

    Sunmark Allergy Relief

    Diphenhydramine HCl 25 mg

     

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF  ANTIHISTAMINE
    diphenhydramine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-983
    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
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    WATER (UNII: 059QF0KO0R)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeCAPSULESize12mm
    FlavorImprint Code T;61;V;25;S4
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49348-983-042 in 1 CARTON09/28/2011
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:49348-983-101 in 1 BOX09/28/2011
    2100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33609/28/2011
    Labeler - Strategic Sourcing Services LLC (116956644)