Label: FIRST AID SHOT THERAPY SLEEP AID- 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 ingredients

    Diphenhydramine HCl 50 mg

  • Purpose (in each bottle)

    Nighttime sleep-aid

  • Uses

    • for the relief of occasional sleeplessness
    • reduces time to fall asleep if you have difficulty falling asleep
  • Warnings

    Do not use

    • for children under 12 years of age
    • with any other product containing diphenhydramine, even one used on skin
    • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
    • with other Nighttime products

    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

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

    When using this product

    • avoid alcoholic beverages

    Stop use and ask a doctor if

    sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

    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:

    • One dose = one bottle (40 mL) at bedtime if needed or as directed by a doctor

    Children under 12 years:

    • Do not use
  • Other information

    • each 40mL contains: sodium 42 mg
    • store between 20-25C°(68-77°F)
  • Inactive ingredients

    alcohol, citric acid, flavors, 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 - 40 mL Bottle Label

    SLEEP
    AID

    FAST
    –LIQUID–
    RELIEF    ®

    FIRST AID
    SHOT THERAPY®

    WARMING PEACH

    FDA
    COMPLIANT

    Diphenhydramine HCl
    Nighttime sleep-aid
    Alcohol 10%

    1.35 FL OZ (40mL)

    PRINCIPAL DISPLAY PANEL - 40 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    FIRST AID SHOT THERAPY SLEEP AID 
    diphenhydramine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57815-091
    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
    ALCOHOL (UNII: 3K9958V90M)  
    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
    FlavorPEACHImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57815-091-011 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 FINALpart33807/01/2016
    Labeler - First Aid Beverages, Inc. (078618157)
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