DYE-FREE ADULT ALLERGY LIQUID MEDICATION (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]

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DYE-FREE ADULT ALLERGY LIQUID MEDICATION (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [AUROHEALTH LLC]
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NDC 58602-517-24
Set ID 3c276bf5-c3ec-4bc9-9370-2899511ef996
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 20 mL]

    Diphenhydramine HCl, USP 50 mg

  • Purpose

    Antihistamine

  • Uses

    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
      • sneezing
      • itchy, watery eyes
      • runny nose
      • 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 you have

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

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

  • When using this product

    • marked drowsiness may occur
    • avoid alcoholic drinks
    • 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 (1-800-222-1222) right away.

  • Directions

    • take every 4 to 6 hours, or as directed by a doctor
    • do not take more than 6 doses in 24 hours
    • not to exceed 300 mg in 24 hours
    • mL = milliliter

    Age (yr)
    		Dose (mL)
    Adult and children 12 years and older
    		10 mL to 20 mL
    Children under 12 years
    		Consult a doctor

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

  • Other information

    • each 20 mL contains: sodium 56 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, flavor, high fructose corn syrup, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucralose

    Questions or Comments?

    1-855-274-4122
     
    Distributed by:
    AUROHEALTH LLC.
    2572 Brunswick Pike
    Lawrenceville, NJ 08648

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

    NDC 58602-517-24
    Primary Health
    MAXIMUM STRENGTH
    Dye-Free Adult
    ALLERGY
    LIQUID MEDICATION
    ANTIHISTAMINE
    DIPHENHYDRAMINE
    HYDROCHLORIDE     50 mg/20 mL
    ORAL SOLUTION     

    Relieves:

    • Runny nose
    • Sneezing
    • Itchy, watery eyes
    • Itchy throat

    Alcohol-Free

    Dye-Free
    Cherry Flavor     
     

    4 FL OZ (118 mL)

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

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

    NDC 58602-517-24
    Primary Health
    MAXIMUM STRENGTH
    Dye-Free Adult
    ALLERGY
    LIQUID MEDICATION
    ANTIHISTAMINE
    DIPHENHYDRAMINE
    HYDROCHLORIDE     50 mg/20 mL
    ORAL SOLUTION     

    Relieves:

    • Runny nose
    • Sneezing
    • Itchy, watery eyes
    • Itchy throat

    Alcohol-Free

    Dye-Free
    Cherry Flavor     
     

    4 FL OZ (118 mL)

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

  • INGREDIENTS AND APPEARANCE
    DYE-FREE ADULT ALLERGY LIQUID MEDICATION 
    diphenhydramine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-517
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CHERRY (UNII: BUC5I9595W)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorYELLOW (Colorless to Pale Yellow) Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-517-241 in 1 CARTON09/24/201808/01/2022
    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 FINALpart34109/24/201808/01/2022
    Labeler - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurohealth LLC078728447MANUFACTURE(58602-517)
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