Label: ALLERGY GET RELIEF- diphenhydramine hydrochloride 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 June 11, 2012

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each caplet)

    Diphenhydramine HCl 25 mg

  • Purpose

    Antihistamine

  • Uses

    temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

    • sneezing
    • runny nose
    • itchy, watery eyes
    • itching of the nose or throat
    • and these symptoms associated with the common cold:
      • sneezing
      • runny nose
  • Warnings

    Do not use with any other products containing diphenhydramine, including one used on skin

    Ask a doctor before use if you have

    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma or
    • 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 beverages
    • 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.

    Overdose warning

    In case of accidental overdose, contact a doctor or Poison Control Center immediately.

  • 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 over1 to 2 caplets
    Children 6 to under 12 years1 caplet
    Children under 6 yearsConsult a doctor
  • Other information

    • store between 20-25 C (68-77 F).Avoid high humidity. Protect from light
    • do not use if pouch is torn or open
    • see side panel for lot number and expiration date
  • Inactive ingredients

    croscarmellose sodium, D&C Red #27, hydroxypropylmethyl cellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide. May contain polysorbate.

  • Questions or comments?

    Call toll free 1-800-570-8650 (M-F 9 am to 5 pm PST)

  • SPL UNCLASSIFIED SECTION

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Benadryl®

    Product manufactured for:
    Eagle Distributors,Inc.
    Los Angeles, CA 90011

  • PRINCIPAL DISPLAY PANEL - 50 Pouch Carton

    Compare to the Active Ingredients in
    Bendaryl® Allergy*

    Allergy
    Get Relief

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

    Diphenhydramine Hci, An Antihistamine

    PRINCIPAL DISPLAY PANEL - 50 Pouch Carton
  • INGREDIENTS AND APPEARANCE
    ALLERGY GET RELIEF 
    diphenhydramine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68737-223
    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
    croscarmellose sodium (UNII: M28OL1HH48)  
    D&C Red No. 27 (UNII: 2LRS185U6K)  
    hypromelloses (UNII: 3NXW29V3WO)  
    lactose (UNII: J2B2A4N98G)  
    magnesium stearate (UNII: 70097M6I30)  
    cellulose, microcrystalline (UNII: OP1R32D61U)  
    polyethylene glycols (UNII: 3WJQ0SDW1A)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorPINKScore2 pieces
    ShapeOVAL (Capsule shape) Size11mm
    FlavorImprint Code AZ;048
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68737-223-0750 in 1 BOX
    12 in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/30/2012
    Labeler - Eagle Distributors,Inc. (929837425)
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