Label: ALLERGY RELIEF- diphenhydramine hcl 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 February 13, 2013

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  • Active ingredient (in each tablet)

    Diphenhydramine HCL 25mg

  • 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 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 take more than 6 doses in 24 hours

    adults and children 12 years of age and over25 mg to 50 mg (1 to 2 tablets)
    children 6 to under 12 years of age25 mg (1 tablet)

    children under 6 years of age

    children under 4 years of age

    ask a doctor

    do not use

  • Other information

    • each tablet contains:calcium 0.1mg
    • store at 59° to 77°F in a dry place
    • protect from light
  • Inactive ingredients

    FD&C red no. 40, hypromellose 2910, hydroxypropyl cellulose, lactose anhydrous, microcrystalline cellulose, polyethylene glycol 6000, sodium starch glycolate, silicic acid anhydride, stearic acid, titanium dioxide

  • Package label

    Allergy Reliefimage of Allergy Relief cartonimage description

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    diphenhydramine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59970-082
    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
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYPROMELLOSE 2910 (50 MPA.S) (UNII: 1IVH67816N)  
    HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeOVALSize11mm
    FlavorImprint Code ZN75
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59970-082-242 in 1 BOX
    110 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/01/2013
    Labeler - Navarro Discount Pharmacies,LLC (094930963)
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