Label: SELECT HEALTH ALLERGY RELIEF- 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 August 26, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 5 mL tsp)

    Diphenhydramine 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

    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

    • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
    • take every 4 to 6 hours
    • do not take more than 6 doses in 24 hours
    • children under 2 years: do not use
    • children 2 to 5 years: do not use unless directed by a doctor
    • children 6 to 12 years: 5 to 10 mL (1 to 2 tsp)
  • Other Information

    • each teaspoon contains: sodium 14 mg
    • store between 20 to 25°C (68 to 77°F)
    • protect from light
    • store in outer carton until contents sused.
  • Inactive Ingredients

    anhydrous citric acid, D&C res #33, FD&C red #40, flavors, glycerin, monoammonium glycyrrhizinate, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose

  • Questions?

    Adverse drug event call (888) 933-3222

  • PRINCIPAL DISPLAY PANEL - 118 ML Bottle Carton

    Children's
    ALLERGY
    RELIEF

    HealthSelect®

    Diphenhydramine HCl
    Antihistamine

    For Temporary Relief of:

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

    For Ages 12 and Older
    Alcohol Free

    NET 4 FL OZ
    (118 ML)

    NDC 49743-3001-1

    Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    SELECT HEALTH ALLERGY RELIEF   CHERRY
    diphenhydramine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49743-3003
    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)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Glycerin (UNII: PDC6A3C0OX)  
    polyethylene glycols (UNII: 3WJQ0SDW1A)  
    sodium citrate (UNII: 1Q73Q2JULR)  
    sodium chloride (UNII: 451W47IQ8X)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49743-3003-1118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34109/01/2011
    Labeler - Axcentria Pharmaceuticals, LLC. (961871501)
    Establishment
    NameAddressID/FEIBusiness Operations
    Axcentria Pharmaceuticals, LLC.961871501MANUFACTURE
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