AMMONIA - ammonia inhalant 
Physicians Total Care, 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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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

Ammonia Inhalant

package label

10 inhalants

NDC 54868-2525-0

Each ampule contains 0.33 mL

Alcohol 35% - Ammonia 15%



Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma      74146
AMMONIA 
ammonia inhalant
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:54868-2525(NDC:39822-9900)
Route of AdministrationRESPIRATORY (INHALATION)DEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMMONIA (AMMONIA) AMMONIA0.045 g  in 0.3 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
FD&C RED NO. 40 
LAVENDER OIL 
WATER 
NUTMEG OIL 
LEMON OIL 
Packaging
#Item CodePackage Description
1NDC:54868-2525-010 in 1 CARTON
10.3 mL in 1 AMPULE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER08/17/201201/15/2013
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIBusiness Operations
Physicians Total Care, Inc.194123980relabel(54868-2525)

Revised: 02/2013
Document Id: e7e9da68-072f-424f-b781-6ba572d52d16
Set id: afc0c5bc-738f-4a19-97e7-6955c0c73203
Version: 4
Effective Time: 20130211
 
Physicians Total Care, Inc.