Label: FIRST AID SHOT THERAPY ALLERGY RELIEF- diphenhydramine hydrochloride solution

  • 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 June 20, 2016

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Diphenhydramine HCl 50 mg

  • Purpose (in each bottle)

    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 and throat
    • temporarily relieves these symptoms due to the common cold:
      • runny nose
      • sneezing
  • 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 emphysema or chronic bronchitis
    • glaucoma
    • difficulty in urination due to enlargement of the prostate gland
    • a sodium-restricted diet

    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
    • alcohol, 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 care professional before use.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • Adults and children 12 years and over:
      • swallow the contents of one bottle
      • repeat every 4-6 hours while symptoms persist, or as directed by doctor
      • do not take more than 6 bottles in 24 hours
    • Children under 12 years: Do not use
  • Other information

    • each 40 ml contains: sodium 44 mg
    • store between 20-25C°(68-77°F)
  • Inactive ingredients

    citric acid, flavor, glycerol, polyoxyl 40 stearate, purified water, sodium benzoate, sodium citrate, sucrose

  • Questions or comments?

    1-877-958-8331 (Monday-Friday 9AM-5PM PST). You may also report serious side effects to this number.

  • SPL UNCLASSIFIED SECTION

    Distributed by
    First Aid Shot Therapy®
    Burlingame, CA 94010

  • PRINCIPAL DISPLAY PANEL - 40mL Bottle Label

    ALLERGY

    FAST
    –LIQUID–
    RELIEF®

    FIRST AID
    SHOT THERAPY®

    TROPICAL

    FDA
    COMPLIANT

    Diphenhydramine HCl
    (Antihistamine)

    1.35 FL OZ (40mL)

    Principal Display Panel - 40mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    FIRST AID SHOT THERAPY ALLERGY RELIEF 
    diphenhydramine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57815-010
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine Hydrochloride50 mg  in 40 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMANGO, PEACHImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57815-010-011 in 1 CARTON07/01/2016
    140 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34107/01/2016
    Labeler - First Aid Beverages, Inc. (078618157)
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