Label: ALLERGY RELIEF- diphenhydramine hcl 25 mg tablet

  • Category: HUMAN OTC DRUG LABEL

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 15, 2020

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  • Active Ingredient

    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
    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 24 mg - store between 20-25°C (68-77°F). Avoid high humidity. Protect from moisture and light

  • 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

  • PRINCIPAL DISPLAY PANEL

    LabelLabel

  • 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
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeOVALSize11mm
    FlavorImprint Code S4
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72090-021-2424 in 1 BOTTLE; Type 0: Not a Combination Product06/29/2020
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/29/2020
    Labeler - Pioneer Life Sciences, LLC (014092742)
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