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Ammonia Inhalants Prescribing Information

Package insert / product label
Dosage form: inhalant

Active ingredient(s)

Ammonia (15%)

Purpose

Inhalant

Indications and Usage for Ammonia Inhalants

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.

Ammonia Inhalants Dosage and Administration

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 and Handling

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)