FIRST AID SHOT THERAPY ALLERGY RELIEF- diphenhydramine hydrochloride solution

First Aid Shot Therapy Allergy Relief by

Drug Labeling and Warnings

First Aid Shot Therapy Allergy Relief by is a Otc medication manufactured, distributed, or labeled by First Aid Beverages, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

FIRST AID SHOT THERAPY ALLERGY RELIEF 
diphenhydramine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57815-010
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M)	Diphenhydramine Hydrochloride	50 mg  in 40 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	MANGO, PEACH	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57815-010-01	1 in 1 CARTON	07/01/2016
1		40 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	07/01/2016

Labeler - First Aid Beverages, Inc. (078618157)