Ammonia Inhalants

Dosage Form: inhalant

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

AMMONIA INHALANTS

Active ingredient(s)

Ammonia (15%)

Purpose

 Inhalant

Use(s)

To prevent or treat fainting

Warnings

Keep away from the Eyes.

For external use only

Stop use and ask a doctor if

 condition persists

Keep out of reach of children

 If swallowed, get medical help or contact a Poison Control Center right away.

Directions

 Directions: hold inhalant away from face and crush between thumb and forefinger. Carefully approach crushed inhalant to nostrils of affected person.

Other information

 Store at room temperature away from light.

Storage

 Store at 20ºC to 25ºC (68ºF to 77ºF)

Inactive ingredients

 Alcohol USP, FDC red dye 40, lavender oil fcc, lemon oil fcc, nutmeg oil fcc, purified water usp

Questions

 Questions? Call 1-866-390-4411 Mon - Fri 9:00 AM - 5:00 PM

Principal Display Panel

Ampule Label

10 ampule carton

 

12 ampule carton

AMMONIA INHALANTS 
ammonia inhalants inhalant
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:39822-9900
Route of Administration RESPIRATORY (INHALATION) DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMMONIA (AMMONIA) AMMONIA 0.045 g  in 0.3 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL  
FD&C RED NO. 40  
LAVENDER OIL  
WATER  
NUTMEG OIL  
LEMON OIL  
Packaging
# Item Code Package Description
1 NDC:39822-9900-1 10 AMPULE (10 AMPULE) in 1 CARTON
1 0.3 mL in 1 AMPULE
2 NDC:39822-9900-2 12 AMPULE (12 APPLICATOR) in 1 CARTON
2 0.3 mL in 1 AMPULE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 02/14/1976
Labeler - X-GEN Pharmaceuticals, Inc. (790169531)
Registrant - X-Gen Pharmaceuticals, Inc. (790169531)
Revised: 08/2012
 
X-GEN Pharmaceuticals, Inc.



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