AMMONIA INHALANTS- ammonia inhalants inhalant 
XGen Pharmaceuticals DJB, Inc.

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.

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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

Ampul Label

Ampule Label

10 pack carton

10 pack carton

12 pack carton

12 pack carton

AMMONIA INHALANTS 
ammonia inhalants inhalant
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:39822-9900
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X) AMMONIA0.045 g  in 0.3 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
ENGLISH LAVENDER OIL (UNII: ZBP1YXW0H8)  
WATER (UNII: 059QF0KO0R)  
NUTMEG OIL (UNII: Z1CLM48948)  
LEMON OIL (UNII: I9GRO824LL)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:39822-9900-110 in 1 CARTON02/14/197609/25/2020
10.3 mL in 1 AMPULE; Type 0: Not a Combination Product
2NDC:39822-9900-212 in 1 CARTON02/14/197609/25/2020
20.3 mL in 1 AMPULE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER02/14/197609/25/2020
Labeler - XGen Pharmaceuticals DJB, Inc. (117380305)

Revised: 4/2020
Document Id: b434aa8c-82f7-459d-b8ec-7aa1e1a10be7
Set id: b23e0801-dd5c-4105-8571-74c32be1e782
Version: 4
Effective Time: 20200407
 
XGen Pharmaceuticals DJB, Inc.