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FDA Approval

Ammonia Inhalants

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Sina Health Inc
DUNS: 047161553
Effective Date
February 4, 2019
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Ammonia(0.045 g in 0.3 mL)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Sina Health Inc

047191553

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Sina Health Inc

Sina Health Inc

Sina Health Inc

047161553

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Ammonia Inhalants

Product Details

NDC Product Code
70385-2003
Route of Administration
RESPIRATORY (INHALATION)
Effective Date
February 4, 2019
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
LAVENDER OILInactive
Code: ZBP1YXW0H8Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
LEMON OILInactive
Code: I9GRO824LLClass: IACT
NUTMEG OILInactive
Code: Z1CLM48948Class: IACT
AmmoniaActive
Code: 5138Q19F1XClass: ACTIBQuantity: 0.045 g in 0.3 mL

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

OTC - ACTIVE INGREDIENT SECTION

Active ingredient(s)

Ammonia (15%)

OTC - QUESTIONS SECTION

Questions

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


INACTIVE INGREDIENT SECTION

Inactive ingredients

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


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