Ammonia Inhalants

Manufacturer
XGen Pharmaceuticals DJB, Inc.
Effective date
2020-04-07
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:07:29

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

Ampule LabelAmpule Label10 pack carton10 pack carton12 pack carton12 pack carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
39822-9900-12020-11-13C16284748780-197449f38-c04a-f6ea-e053-dbdaa90aa703AMMONIA INHALANTS
39822-9900-22020-11-13C16284748780-197449f38-c04a-f6ea-e053-dbdaa90aa703AMMONIA INHALANTS
39822-9900-12019-11-13C16284748780-197449f38-c04a-f6ea-e053-dbdaa90aa703AMMONIA INHALANTS
39822-9900-22019-11-13C16284748780-197449f38-c04a-f6ea-e053-dbdaa90aa703AMMONIA INHALANTS

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AMMONIAACTIVE INGREDIENT5138Q19F1X2
AMMONIAACTIVE MOIETY5138Q19F1X2
ALCOHOLINACTIVE INGREDIENT3K9958V90M2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA2
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H82
LEMON OILINACTIVE INGREDIENTI9GRO824LL2
NUTMEG OILINACTIVE INGREDIENTZ1CLM489482
WATERINACTIVE INGREDIENT059QF0KO0R2

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
39822-990039822-9900-1, 39822-9900-2

Ingredients#

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

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

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 95 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASHAMPOO / TOPICAL2 mgExact identifier — unii candidate
28 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
28 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
LAVENDER OILLAVENDER OILZBP1YXW0H8GEL / TOPICAL0.1 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET / BUCCAL0.01 mgExact identifier — unii candidate
28 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASUSPENSION / ORAL100 mg/5mlExact identifier — unii candidate
28 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
LEMON OILLEMON OIL, COLD PRESSEDI9GRO824LLPASTE, DENTIFRICE / DENTAL0.7 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET, EXTENDED RELEASE / ORAL2.22 mgExact identifier — unii candidate
28 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET / ORAL7 mgExact identifier — unii candidate
28 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
LEMON OILLEMON OIL, COLD PRESSEDI9GRO824LLGEL / TOPICAL0.05 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
NUTMEG OILNUTMEG OILZ1CLM48948ELIXIR / ORAL4.5 mg/5mlExact identifier — unii candidate
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, COATED PELLETS / ORALNAExact identifier — unii candidate
28 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
28 equally ranked IID candidates
NUTMEG OILNUTMEG OILZ1CLM48948LIQUID / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
2 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOAELIXIR / ORAL12.5 mg/5mlExact identifier — unii candidate
28 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASUSPENSION/ DROPS / ORAL1 mgExact identifier — unii candidate
28 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
28 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASOLUTION / DENTALNAExact identifier — unii candidate
28 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASYRUP / ORAL3 mgExact identifier — unii candidate
28 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
LEMON OILLEMON OIL, COLD PRESSEDI9GRO824LLCAPSULE / ORAL8.5 mgExact identifier — unii candidate
4 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, COATED / ORALNAExact identifier — unii candidate
28 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, DELAYED RELEASE PELLETS / ORAL0.02 mgExact identifier — unii candidate
28 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOAGUM, CHEWING / BUCCAL48 mgExact identifier — unii candidate
28 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET / SUBLINGUALNAExact identifier — unii candidate
28 equally ranked IID candidates

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
b434aa8c-82f7-459d-b8ec-7aa1e1a10be7b23e0801-dd5c-4105-8571-74c32be1e7822020-04-07WarningsExact identifier
spl id: b434aa8c-82f7-459d-b8ec-7aa1e1a10be7
spl set id: b23e0801-dd5c-4105-8571-74c32be1e782

Reported adverse events (FAERS/openFDA)#

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