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 February 6, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 5 mL = 1 teaspoon)

    Diphenhydramine, USP HCl 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 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.

    Consult your pharmacist or health care provider for any appropriate, additional dosage delivery device necessary for use when a physician recommends a dose that is different than the doses that appear on the dosage delivery device that accompanies this product.

    Age (yr)Dose (TSP)
    TSP = teaspoon
    under 6 yrs.ask a doctor
    6 to under 121-2 TSP
    or as directed by a doctor

    Keep out of reach of children.

    Overdose warning

    Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Prompt medical attention is critical, even if you do not notice any signs or symptoms.

  • Other information

    • each teaspoon contains: sodium 7 mg
    • store between 20°-25°C (68°-77°F)
    • tamper evident: do not use if foil seal over the mouth of the bottle is torn, broken, or missing.
  • Directions

    • may be given every 4 to 6 hours
    • do not use more than 6 times in 24 hours
    • use only enclosed dosing cup to dose this product. Do not use any other dosing device.
  • Questions?

    877-434-2036

  • Inactive ingredients

    artificial flavor, citric acid anhydrous, CMC sodium, glycerin, polysorbate, propylene glycol, purified water, sodium benzoate, sodium saccharin, sodium citrate dihydrate, sorbitol solution.

  • SPL UNCLASSIFIED SECTION

    Distributed by: AccuDial® Pharmaceutical, Inc. Palm Beach Gardens, FL 33408

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

    ACCUDIAL®

    Children's
    Allergy

    Diphenhydramine HCl
    Oral Solution Antihistamine

    Relieves Sneezing
    • Itchy, Watery Eyes
    Runny Nose • Itchy Throat

    Earth-Friendly
    Package!

    For Ages 6 yrs to under 12 yrs

    Tamper Evident

    Compares to Children's
    Benadryl® Allergy

    Dye-Free
    BUBBLEGUM
    FLAVOR

    NDC 45014-161-04
    4 FL. OZ. (118 mL)

    PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    ALLERGY 
    diphenhydramine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45014-161
    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
    Anhydrous Citric Acid (UNII: XF417D3PSL)  
    Sodium (UNII: 9NEZ333N27)  
    Glycerin (UNII: PDC6A3C0OX)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Water (UNII: 059QF0KO0R)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Trisodium Citrate Dihydrate (UNII: B22547B95K)  
    Sorbitol (UNII: 506T60A25R)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45014-161-04118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34102/01/2013
    Labeler - Accudial Pharmaceutical, Inc. (831999201)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bio-Pharm, Inc.801652546ANALYSIS(45014-161) , MANUFACTURE(45014-161) , RELABEL(45014-161) , REPACK(45014-161)
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