Label: ALLERGY- diphenhydramine hydrochloride liquid

  • 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 November 2, 2009

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  • SPL UNCLASSIFIED SECTION

    ALLERGY

    Drug Facts

  • Active ingredient (in each 5 mL)1

    Diphenhydramine HCl 12.5 mg

    1
    5mL = one teaspoon
  • 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 the child has

    • a breathing problem such as chronic bronchitis
    • glaucoma
    • a sodium-restricted diet

    Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers

    When using this product

    • marked drowsiness may occur
    • sedatives and tranquilizers may increase drowsiness
    • excitability may occur, especially in children

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

  • Directions

    • take every 4 to 6 hours
    • do not take more than 6 doses in 24 hours
    • to find right dose, use rotating bottle label to dose by weight; otherwise, use chart below to dose by age
    • specifically designed for use with enclosed dosing spoon. Use only enclosed dosing spoon to dose this product. Do not use any other dosing device
    children under 2 yearsdo not use
    children 2 to 5 yearsdo not use unless directed by a doctor
    children 6 to under 12 years5 mL to 10 mL
    (1 to 2 teaspoonfuls)
  • Other information

    each teaspoon contains:

    • sodium 3 mg
    • store between 20°-25°C (68°-79°F). Protect from light. Store in outer carton until contents used.
  • Inactive ingredients

    artificial flavor, citric acid, D&C red no. 33, FD&C red no. 40, glycerin, polysorbate 20, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol.

  • Questions?

    877-434-2036

  • PRINCIPAL DISPLAY PANEL - 118 mL Carton

    CHILDREN'S
    ACCUDIAL

    ROTATING DOSING LABEL

    ACCURATE DOSING
    BY WEIGHT

    Diphenhydramine HCl
    Oral Solution
    Anthistamine

    FOR RELIEF OF
    Sneezing
    Itchy, Watery Eyes
    Runny Nose
    Itchy Throat

    For Ages 6 to under 12

    Alcohol & Sugar Free
    Compares to Children's
    Benadryl® Allergy.

    CHERRY
    FLAVOR

    4 FL. OZ.
    (118 mL)
    NDC 45014-140-04

    Allergy

    Principal Display Panel - 118 mL Carton
  • SPL UNCLASSIFIED SECTION

  • INGREDIENTS AND APPEARANCE
    ALLERGY 
    diphenhydramine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45014-140
    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 (UNII: SB8ZUX40TY)  
    Sorbitol (UNII: 506T60A25R)  
    Product Characteristics
    ColorPINKScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45014-140-04118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34110/26/2009
    Labeler - Accudial Pharmaceutical, Inc. (831999201)
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