Label: ALLERGY- 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 October 6, 2021

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  • Active ingredient

    (in each caplet)

    Diphenhydramine HCl (25 mg)

  • PURPOSE

    Antihistamine

  • Warnings

    Do not use

    • to make a child sleepy
    • with any other product containing Diphenhydramine, even one used on the skin

    Ask a doctor before use if you have

    • trouble urinating due to an enlarged prostate gland
    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma

    Ask a doctor or pharmacist before use if you are

    • taking sedatives or tranquilizers

    When using this product

    • avoid alcoholic drinks
    • marked drowsiness may occur
    • excitability may occur, especially in children
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery

    If pregnant or breast-feeding

    ask a health professional before use

    Keep out of the reach of children

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • take every 4 to 6 hours, or as directed by a doctor
    • do not take more than 6 doses in 24 hours

    adults and children 12 years and over         1 to 2 tablets

    children 6 to under 12 years                       1 tablet

    children under 6 years                               ask a doctor

  • Inactive ingredients

    colloidal silicon dioxide, corn starch, D & C red # 27 Aluminum lake, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, stearic acid, talc, titanium dioxide

  • Questions or comments?

    Call 1-844-428-2538

  • Uses

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

    • sneezing
    • nasal congestion
    • runny nose
    • itchy, watery eyes

    Temporarily relieves these symptoms due to common cold

    • runny nose
    • sneezing
  • PRINCIPAL DISPLAY PANEL

    ALLERGY

    Diphenhydramine HCI 25mg | Antihistamine

    Runny Nose Nasal Congestion

    Sneezing Itchy Watery Eyes

    COMPARE TO THE ACTIVE INGREDIENTS IN

    BENADRYL® *

    6 TABLETS

    ALLERGY

  • INGREDIENTS AND APPEARANCE
    ALLERGY 
    diphenhydramine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29485-7007
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    Colorpink (Pink) Scoreno score
    ShapeOVALSize11mm
    FlavorImprint Code PH25
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29485-7007-66 in 1 PACKAGE03/13/2019
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/13/2019
    Labeler - Mechanical Servants, LLC (005530951)
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