Label: DIPHENHYDRAMINE HYDROCHLORIDE liquid

  • 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 5, 2012

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each teaspoon (5 mL))

    Diphenhydramine HCl USP 12.5 mg

  • 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
  • Warnings

    Do not use

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

    Ask a doctor before use if you have

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

    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
    • 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 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
    • do not take more than 6 doses in 24 hours
    adults and children 12 years and over2 to 4 teaspoons (25 mg to 50 mg)
    children 6 to under 12 yearsask a doctor
    children 4 to 5 yearsdo not use unless directed by a doctor
    children under 4 yearsdo not use
  • Other information

    • each teaspoon (5 mL) contains: sodium 5 mg
    • store between 20°-25°C (68°-77°F). Protect from light.
  • Inactive ingredients

    artificial cherry flavors, citric acid, D&C Red #33, FD&C Red #40, glycerin, polysorbate 20, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution

  • Questions?

    call 1-888-838-2872, weekdays, 8 AM - 5 PM Eastern Time

  • PRINCIPAL DISPLAY PANEL


    NDC 54868-1227-0

    image of package label

    TAMPER-EVIDENT


    Diphenhydramine HCl USP
    12.5 mg per 5 mL)

    ONE PINT (473 mL)

    ANTIHISTAMINE

    ALCOHOL-FREE
    SUGAR-FREE
    CHERRY-FLAVORED

    TAMPER-EVIDENT: Do not use this product if
    inner foil seal over the mouth of the bottle
    is cut, torn, broken or missing.

    NOT FOR HOUSEHOLDS
    WITH YOUNG CHILDREN


  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-1227(NDC:0182-6168)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine12.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    citric acid monohydrate (UNII: 2968PHW8QP)  
    D&C Red no. 33 (UNII: 9DBA0SBB0L)  
    FD&C Red no. 40 (UNII: WZB9127XOA)  
    glycerin (UNII: PDC6A3C0OX)  
    polysorbate 20 (UNII: 7T1F30V5YH)  
    water (UNII: 059QF0KO0R)  
    sodium benzoate (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)  
    sodium citrate (UNII: 1Q73Q2JULR)  
    sorbitol (UNII: 506T60A25R)  
    Product Characteristics
    ColorPINKScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-1227-0473 mL in 1 BOTTLE, PLASTIC
    2NDC:54868-1227-2118 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/22/2002
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel
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