FIRST AID SHOT THERAPY SLEEP AID- diphenhydramine hydrochloride solution

First Aid Shot Therapy Sleep Aid by

Drug Labeling and Warnings

First Aid Shot Therapy Sleep Aid 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 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)

INGREDIENTS AND APPEARANCE

FIRST AID SHOT THERAPY SLEEP AID 
diphenhydramine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57815-091
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
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
Shape		Size
Flavor	PEACH	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57815-091-01	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	part338	07/01/2016

Labeler - First Aid Beverages, Inc. (078618157)