FIRST AID SHOT THERAPY ALLERGY RELIEF- 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® Allergy Relief®

Drug Facts

Active ingredient

Diphenhydramine HCl 50 mg

Purpose (in each bottle)

Antihistamine

Uses

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

Other information

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.

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
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)

Revised: 6/2016
Document Id: 03980abd-259f-40df-86f1-38f386edabdf
Set id: af7c4f91-a3d8-4c16-b82c-7e9867986d0b
Version: 1
Effective Time: 20160620
 
First Aid Beverages, Inc.