AMMONIA INHALANTS- ammonia inhalants inhalant 
REMEDYREPACK 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

OTC - ACTIVE INGREDIENT

Ammonia (15%)

 

OTC - PURPOSE

 Inhalant

 

INDICATIONS & USAGE

To prevent or treat fainting

 

WARNINGS

Keep away from the Eyes.

 

 condition persists

 

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

 

DOSAGE & ADMINISTRATION

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

 

SPL UNCLASSIFIED

 Store at room temperature away from light.

 

STORAGE AND HANDLING

 Store at 20ºC to 25ºC (68ºF to 77ºF)

 

INACTIVE INGREDIENT

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

 

OTC - QUESTIONS

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

 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

DRUG: Ammonia Inhalants


GENERIC: Ammonia Inhalants


DOSAGE: INHALANT


ADMINSTRATION: RESPIRATORY (INHALATION)


NDC: 61786-241-08


ACTIVE INGREDIENT(S):

  • AMMONIA 0.045g in 0.3mL


INACTIVE INGREDIENT(S):

  • ALCOHOL
  • NUTMEG OIL
  • WATER
  • FD&C RED NO. 40
  • LAVENDER OIL
  • LEMON OIL


PACKAGING: 0.3 mL in 1 AMPULE


OUTER PACKAGING: 10 AMPULE in 1 CARTON




MM1

MM2

AMMONIA INHALANTS 
ammonia inhalants inhalant
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61786-241(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)  
NUTMEG OIL (UNII: Z1CLM48948)  
WATER (UNII: 059QF0KO0R)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
LEMON OIL (UNII: I9GRO824LL)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61786-241-0810 in 1 CARTON03/24/201503/21/2017
10.3 mL in 1 AMPULE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/24/201503/21/2017
Labeler - REMEDYREPACK INC. (829572556)

Revised: 3/2017
Document Id: 4b436cae-f737-66c5-e054-00144ff88e88
Set id: 48d475d5-aac1-4f16-b627-e164682e8979
Version: 2
Effective Time: 20170321
 
REMEDYREPACK INC.