Label: DIPHENHIST- 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 March 20, 2012

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 5mL teaspoonful)

    Diphenhydramine HCl USP 12.5 mg

  • Purpose

    Antihistamine

  • Uses

    temporarily relieves these symptoms of hay fever or other upper respiratory allergies

    • runny nose
    • sneezing
    • itchy, water eyes
    • itchy nose or throat
  • Warnings

    Do not use 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

    • you may get very drowsy
    • 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 reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • take every 4 – 6 hours
    • do not take more than 6 doses in 24 hours
    adults and children 12 years and over2 - 4 teaspoonfuls
    children 6 to under 12 years1 - 2 teaspoonfuls
    children under 6do not use
  • Other information

    • each teaspoonful (5 mL) contains:
      sodium 5 mg
    • store between 20°-25° C (68°-77°F)
    • protect from light. Store in outer carton until contents used
  • Inactive ingredients

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

  • Questions or comments?

    call 1-800-645-2158, 9 am - 5pm ET, Monday - Friday

  • PRINCIPAL DISPLAY PANEL

    COMPARE TO
    ACTIVE INGREDIENT IN
    BENADRYL®
    ALLERGY LIQUID*

    CHILDREN'S ALCOHOL-FREE
    ALLERGY MEDICATION

    Diphenhist®

    ORAL SOLUTION

    Diphenydramine HCI, USP

    Antihistamine

    For Temporary Relief of

    Symptoms of Upper

    Respiratory Allergies

    and Hay Fever

    4 fl oz
    (118 mL)

    Diphenhist (Diphenhydramine) 12.5mg/5ml

  • INGREDIENTS AND APPEARANCE
    DIPHENHIST 
    diphenhydramine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42254-184(NDC:0536-0770)
    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)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Water (UNII: 059QF0KO0R)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Sodium Citrate (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)  
    Sorbitol (UNII: 506T60A25R)  
    Product Characteristics
    ColorPINKScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42254-184-04118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/26/2009
    Labeler - Rebel Distributors Corp (118802834)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rebel Distributors Corp118802834RELABEL, REPACK
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