FDA.reportPublic FDA data

Ammonia Inhalants

Manufacturer
Sina Health Inc
Effective date
2019-02-04
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 20:27:43

Label at a glance#

ProductAmmonia Inhalants
Active ingredientAMMONIA
Label structure10 sections

Dosage and administration

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

Storage and handling

 Store at 20ºC to 25ºC (68ºF to 77ºF)

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ammonia (15%)

Purpose

OTC - PURPOSE SECTION

 Inhalant

Use(s)

INDICATIONS & USAGE SECTION

To prevent or treat fainting

Warnings

WARNINGS SECTION

Keep away from the Eyes.

For external use only

SPL UNCLASSIFIED SECTION

Stop use and ask a doctor if

OTC - STOP USE SECTION

 condition persists

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

SPL UNCLASSIFIED SECTION

 Store at room temperature away from light.

Storage

STORAGE AND HANDLING SECTION

 Store at 20ºC to 25ºC (68ºF to 77ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions

OTC - QUESTIONS SECTION

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdppdp

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1299889ammonia 15 % Nasal InhalantPSN3
1299889ammonia 150 MG/ML Nasal InhalantSCD3
1299889ammonia 0.045 GM per 0.3 ML Nasal InhalantSY3
1299889ammonia 0.3 ML Nasal InhalantSY3
1299889ammonia 15 % Nasal InhalantSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70385-2003-32020-09-27C16284748780-1ab0e2407-2c28-f274-e053-dbdaa90a6471AMMONIA INHALANTS
70385-2003-32020-09-25C16284748780-1ab0e2407-2c28-f274-e053-dbdaa90a6471AMMONIA INHALANTS
70385-2003-32020-07-22C16284748780-1ab0e2407-2c28-f274-e053-dbdaa90a6471AMMONIA INHALANTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70385-2003-3Ammonia Inhalants3 in 1 BAGINHALANT33
70385-2003-3Ammonia Inhalants0.33 mL in 1 AMPULEINHALANT0.333

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70385-2003AMMONIA INHALANTS INHALANT [SINA HEALTH INC]3Legacy NDC, 2 package rows20190205_4cc59056-a5a8-696d-e054-00144ff88e88.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
39822-9900-1EA - Each39822-99008ae49540-cabd-442c-a686-57a5ac392a5112013-02-13
39822-9900-2EA - Each39822-9900435e5989-ad6d-40bc-a534-5d432329db4612013-02-13

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70385-200370385-2003-3
39822-9900

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
FD&C RED NO. 40WZB9127XOAIACT
LAVENDER OILZBP1YXW0H8IACT
WATER059QF0KO0RIACT
NUTMEG OILZ1CLM48948IACT
LEMON OILI9GRO824LLIACT
AMMONIA5138Q19F1XACTIB

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
8117ec68-5774-e83b-e053-2a91aa0a9bf24cc59056-a5a8-696d-e054-00144ff88e882019-02-04WarningsExact identifier
spl id: 8117ec68-5774-e83b-e053-2a91aa0a9bf2
spl set id: 4cc59056-a5a8-696d-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.