DYE-FREE CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]

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DYE-FREE CHILDRENS ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]
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NDC 58602-501-24
Set ID bb5f9226-cf5b-491d-a329-030f70d1218f
Category Human OTC Drug Label
Packager Aurohealth LLC
Generic Name
Product Class
Product Number
Application Number PART341
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  • Drug Facts

    Active ingredient [in each 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 the child has

    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • a sodium-restricted diet
  • Ask a doctor or pharmacist before use if you

    are taking sedatives or tranquilizers

  • When using this product

    • sedatives and tranquilizers may increase drowsiness
    • marked drowsiness may occur
    • 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, or as directed by a doctor
    • do not take more than 6 doses in 24 hours
    • mL = milliliter 

    Age (yr)
    		Dose (mL)
    children under 6 years of age
    		ask a doctor
    children 6 years to under 12 years of age
    		5 mL to 10 mL

    Attention: Use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

  • Other information

    • each 5 mL contains: sodium 9 mg
    • store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used
    • see bottom panel for lot number and expiration date
  • Inactive ingredients

    anhydrous citric acid, carboxymethyl cellulose sodium, flavor, glycerin, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution


    Questions or Comments?

    1-855-274-4122


    * This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Benadryl® Dye Free Allergy.

    Distributed by:
    Aurohealth LLC.
    2572 Brunswick Pike,
    Lawrenceville, NJ 08648

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 FL OZ Container Label (118 mL Bottle)

    NDC 58602-501-24
    PrimaryHealth

    COMPARE TO children’s
    Benadryl® active
    ingredient*

    Dye-Free Children's
    ALLERGY
    LIQUID MEDICATION

    ANTIHISTAMINE


    Diphenhydramine Hydrochloride
    12.5 mg/5 mL
    Oral Solution


    Relieves:

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

    Sugar &
    Alcohol Free



    Dye-Free
    Bubble Gum Flavored

    4 FL OZ (118 mL)

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 FL OZ Container Label (118 mL Bottle)

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 FL OZ Container Carton Label (118 mL Bottle)

    NDC 58602-501-24
    PrimaryHealth

    COMPARE TO children’s
    Benadryl® active
    ingredient*

    Dye-Free Children's
    ALLERGY
    LIQUID MEDICATION

    ANTIHISTAMINE


    Diphenhydramine Hydrochloride
    12.5 mg/5 mL
    Oral Solution


    Relieves:

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

    Sugar &
    Alcohol Free



    Dye-Free
    Bubble Gum Flavored

    4 FL OZ (118 mL)




    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 FL OZ Container Carton Label (118 mL Bottle)

  • INGREDIENTS AND APPEARANCE
    DYE-FREE CHILDRENS ALLERGY 
    diphenhydramine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-501
    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)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorWHITE (Colorless) Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-501-241 in 1 CARTON09/01/201810/01/2021
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34109/01/201810/01/2021
    Labeler - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurohealth LLC078728447MANUFACTURE(58602-501)
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