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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  • Active ingredient (in each 5 mL teaspoonful)

    Diphenhydramine HCl 12.5 mg

  • Purpose

    Antihistamine

  • Uses

    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • sneezing
    • itching of the nose or throat
    • runny nose
    • itchy, watery eyes
    • temporarily relieves these symptoms due to the common cold:
    • sneezing
    • runny nose
  • Warnings

    Do not use

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

    Ask a doctor before use if you have

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

    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 reach of children.

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

  • Directions

    • if needed, take every 4-6 hours
    • do not take more than 6 doses in 24 hours

    children under 4

    years of age    		do not use

    children 4 to under 6

    years of age    		do not use unless directed by a doctor

    children 6 to under

    12 years of age

    1 to 2 teaspoonfuls

    (12.5 mg to 25 mg)

    adults and children

    12 years of age

    and over

    2 to 4 teaspoonfuls

    (25 mg to 50 mg)
  • Other information

    • each teaspoonful contains: sodium 15 mg
    • store at 20°-25°C (68°-77°F)
  • Inactive ingredients

    citric acid, D&C red no. 33, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel


    Diphenhydramine Hydrochloride

    12.5 mg/ 5 mL

    NDC 54868-5622-0

    image of package label


    Relieves:

    Sneezing

    Itchy, Watery Eyes

    Runny Nose

    Itchy Throat

    See New Warning and Dosing Directions

    Cherry Flavored

    4 fl oz (118 mL)

    Alcohol Free



    Additional barcode labeling by:
    Physicians Total Care, Inc.
    Tulsa, Oklahoma      74146
  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-5622(NDC:24385-379)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 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)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorRED (Bluish-Red) Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-5622-01 in 1 CARTON
    1118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/29/2006
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel
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