85248-035update

Manufacturer
Jiangxi Yudexi Pharmaceutical Co., LTD
Effective date
2026-06-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-06-17 05:10:11

Label at a glance#

ProductBOTASUN SMELLING SALTS
Active ingredientAMMONIA
Label structure13 sections

Dosage and administration

Hold bottle 10-15 cm (4-6 inches) from nostrils.Inhale gently. Do not place directly inside the nostrils.Do not inhale for more than 2 seconds per use.Do not use more than once every 60 minutes.Do not use more than 10 times per day.Use only as needed. If symptoms persist, consult a healthcare professional.

Storage and handling

Store in a cool, dry place at 15-25°C (59-77°F). Avoid freezing, excessive heat above 40°C (104°F), and direct sunlight. Do not use if safety seal under cap is broken .

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ammonia (released from solution) 15%

Purpose

OTC - PURPOSE SECTION

For instant stimulation & focus during sports

Use

INDICATIONS & USAGE SECTION

For instant stimulation & focus during sports

Warnings

WARNINGS SECTION

For inhalation use only. Do not ingest or apply to skin.Use only in a well-ventilated area.Do not use in enclosed spaces.Avoid contact with eves. ears, and mouth.If product gets into eyes, rinse thoroughly with water for 15 minutes and seek medical help.May cause nasal irritation, coughing, or shortness of breath. Discontinue use if discomfort occurs and get fresh air immediately.Not recommended for individuals with:respiratory conditions (such as asthma or emphysema), heart disease, high blood pressure,or allergy to ammonia or strong odors.

Do not use

OTC - DO NOT USE SECTION

If you have respiratory conditions such as asthma or emphysema.
If you have heart disease or high blood pressure.
If you are allergic to ammonia or strong odors.

When Using

OTC - WHEN USING SECTION

Avoid contact with eves. ears, and mouth.If product gets into eyes, rinse thoroughly with water for 15 minutes and seek medical help.
May cause nasal irritation, coughing, or shortness of breath. Discontinue use if discomfort occurs and get fresh air immediately.


Stop Use

OTC - STOP USE SECTION

Not recommended for individuals with:respiratory conditions (such as asthma or emphysema), heart disease, high blood pressure,
or allergy to ammonia or strong odors.

Ask Doctor

OTC - ASK DOCTOR SECTION

Not recommended for individuals with:respiratory conditions (such as asthma or emphysema), heart disease, high blood pressure,
or allergy to ammonia or strong odors.

Keep Oot Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Directions

DOSAGE & ADMINISTRATION SECTION

Hold bottle 10-15 cm (4-6 inches) from nostrils.Inhale gently. Do not place directly inside the nostrils.Do not inhale for more than 2 seconds per use.Do not use more than once every 60 minutes.Do not use more than 10 times per day.Use only as needed. If symptoms persist, consult a healthcare professional.

Other information

STORAGE AND HANDLING SECTION

Store in a cool, dry place at 15-25°C (59-77°F).
Avoid freezing, excessive heat above 40°C (104°F), and direct sunlight.
Do not use if safety seal under cap is broken .

Inactive ingredients

INACTIVE INGREDIENT SECTION

Alcohol, Cotton, Peppermint Oil.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1515

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-136979843980111GTIN-13: 6979843980111
EAN-13: 6979843980111
GTIN storage (14 digits): 06979843980111
fde987d35347ff884b8272977028790e.jpg
BarcodeEAN-138976833980111GTIN-13: 8976833980111
EAN-13: 8976833980111
GTIN storage (14 digits): 08976833980111
fde987d35347ff884b8272977028790e.jpg

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85248-03585248-035-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
AMMONIA5138Q19F1XACTIB
COTTON70LDW53ROOIACT
ALCOHOL3K9958V90MIACT
PEPPERMINT OILAV092KU4JHIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22026-03-26full-release2026-06-01 01:51:42
12026-01-31monthly-update2026-06-03 17:56:01

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
5441e361-3e76-c174-e063-6294a90af59c49aa685f-ced5-4da3-e063-6394a90a03c32026-06-14WarningsExact identifier
spl id: 5441e361-3e76-c174-e063-6294a90af59c
spl set id: 49aa685f-ced5-4da3-e063-6394a90a03c3

Reported adverse events (FAERS/openFDA)#

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