FIRST AID SHOT THERAPY SLEEP AID- diphenhydramine hydrochloride solution 
First Aid Beverages, Inc.

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.

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First Aid Shot Therapy® Sleep Aid

Drug Facts

Active ingredients

Diphenhydramine HCl 50 mg

Purpose (in each bottle)

Nighttime sleep-aid

Uses

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:

Children under 12 years:

Other information

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.

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
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)

Revised: 6/2016
Document Id: f3c496b1-188e-4a54-8c75-62da66a7c533
Set id: 43af9e87-66f9-4a95-8504-7fa352e683a9
Version: 1
Effective Time: 20160620
 
First Aid Beverages, Inc.