Label: ALLERGY RELIEF- diphenhydramine hcl 25 mg 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 October 1, 2018

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  • Drug FactsActive 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
    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 DOCTOR

    Ask a doctor before use if you have

    • glaucoma
    • troble urinating due to an enlarged prostate gland
    • a breathing problem such as emphysema or chronic bronchitis
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you aretaking 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
  • PREGNANCY

    If pregnant or breast-feeding, ask a health professional before use. 

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • if needed, repeat dose every 4 to 6 hours
    • do not take more than 6 times in 24 hours
    • adults and children 12 years of age or older - 1 to 2 caplets
    • children 6 to under 12 years - 1 caplet
    • children under 6 years of age - do not use.
  • Other information

    each tablets contains:

    calcium 15 mg
    store between 20-25°C (68-77°F). Avoid high humidity

  • Inactive ingredients

    dicalcium phosphate, microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, OPADRY II

  • Questions or comments?

    Call 1-732-698-5070 Monday through Friday 9AM–5PM EST or www.pioneerlifesciences.com

    Distributed by:
    Pioneer Life Sciences
    40E Cotters Lane, Suite A
    East Brunswick, NJ 08816

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    diphenhydramine hcl 25 mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72090-021
    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
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeOVALSize11mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72090-021-25250 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/31/2018
    Labeler - Pioneer Life Sciences, LLC (014092742)
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