FDA.reportPublic FDA data

GO TIME

Manufacturer
Mountain Top Labs, LLC
Effective date
2012-09-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:33:09

Label at a glance#

ProductGO TIME
Active ingredientAMMONIA
Label structure9 sections

Indications and uses

To arouse consciousness and restore mental alertness.

Dosage and administration

Hold inhalant away from face and crush between thumb and forefinger.  Carefully approach crushed inhalant to nostril until desired effect is achieved.

Storage and handling

Store at room temperature away from light.

Label contents#

Full prescribing information#

Active ingredient (each inhalant)

OTC - ACTIVE INGREDIENT SECTION

Ammonia 4.5%

Purpose

OTC - PURPOSE SECTION

Reflex Stimulant

Uses

INDICATIONS & USAGE SECTION

To arouse consciousness and restore mental alertness.

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use if you have breathing problems such as asthma or emphysema.

OTC - WHEN USING SECTION

When using this product avoid contact with the eyes.

OTC - STOP USE SECTION

Stop use and ask a doctor if you experience any adverse effects.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Hold inhalant away from face and crush between thumb and forefinger.  Carefully approach crushed inhalant to nostril until desired effect is achieved.

Other information

STORAGE AND HANDLING SECTION

Store at room temperature away from light.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Alcohol USP, Cinnamon Cassia Oil, Eucalyptus Oil, FD and C Blue Dye #1, Purified Water USP

Questions?

OTC - QUESTIONS SECTION

Call 1-801-448-6809

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 53063-1113-1NDC 53063-1113-1

NDC 53063-1113-1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1312484ammonia 4.5 % Nasal InhalantPSN1
1312484ammonia 45 MG/ML Nasal InhalantSCD1
1312484ammonia 4.5 % Nasal InhalantSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53063-1113-22020-01-31C16284748780-19d75b9d0-df1e-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53063-1113-1GO TIME0.3 mL in 1 AMPULEINHALANT0.31
53063-1113-2GO TIME4 in 1 BOXINHALANT41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53063-1113GO TIME (AMMONIA) INHALANT [MOUNTAIN TOP LABS, LLC]1Legacy NDC, 2 package rows20120929_bd4b2cc4-b9ed-4415-b9a4-5fdff8aa292d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AMMONIAACTIVE INGREDIENT5138Q19F1X1
AMMONIAACTIVE MOIETY5138Q19F1X1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
CINNAMON OILINACTIVE INGREDIENTE5GY4I6YCZ1
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI6621
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53063-111353063-1113-1, 53063-1113-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
AMMONIA5138Q19F1XACTIB
ALCOHOL3K9958V90MIACT
CINNAMON OILE5GY4I6YCZIACT
EUCALYPTUS OIL2R04ONI662IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
WATER059QF0KO0RIACT

Source Document#

Source XML · Source PDF

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 · 103 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPOWDER, FOR SOLUTION / ORAL0.04 mg/5mlExact identifier — unii candidate
37 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDFILM / SUBLINGUAL0.07 mgExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDDOUCHE / VAGINALNAExact identifier — unii candidate
37 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / ORAL1.13 mg/15mlExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii candidate
37 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, COATED / ORAL0.52 mgExact identifier — unii candidate
37 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / TOPICAL0.01 %w/wExact identifier — unii candidate
37 equally ranked IID candidates
CINNAMON OILCINNAMON OILE5GY4I6YCZPASTILLE / ORAL4 mgExact identifier — unii candidate
6 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDELIXIR / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, FILM COATED / ORAL0.16 mgExact identifier — unii candidate
37 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
CINNAMON OILCINNAMON OILE5GY4I6YCZELIXIR / ORAL0.58 mg/5mlExact identifier — unii candidate
6 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
EUCALYPTUS OILEUCALYPTUS OIL2R04ONI662SYRUP / ORALNAExact identifier — unii candidate
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDLIQUID / TOPICALNAExact identifier — unii candidate
37 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDLOTION / TOPICALNAExact identifier — unii candidate
37 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDFILM, SOLUBLE / ORAL0.04 mgExact identifier — unii candidate
37 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCONCENTRATE / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDLIQUID / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCONCENTRATE / BUCCALNAExact identifier — unii candidate
37 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, COATED PELLETS / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSHAMPOO / TOPICAL0.75 %w/wExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSYRUP / ORAL0.05 mg/5mlExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDPASTE / DENTALNAExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSUSPENSION / ORAL1 mgExact identifier — unii candidate
37 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, DELAYED RELEASE PELLETS / ORAL0.01 mgExact identifier — unii candidate
37 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
ae3e24ae-ab8b-46af-a0db-1ba9a3802bc6bd4b2cc4-b9ed-4415-b9a4-5fdff8aa292d2012-09-28WarningsExact identifier
spl id: ae3e24ae-ab8b-46af-a0db-1ba9a3802bc6
spl set id: bd4b2cc4-b9ed-4415-b9a4-5fdff8aa292d

Reported adverse events (FAERS/openFDA)#

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