Active Ingredient
Ammonia (released from solution) 15%
Sylvirene Smelling Salts Inhalant
FDA Label NDC 85248-140
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jiangxi Yudexi Pharmaceutical Co., Ltd for the product Sylvirene Smelling Salts (NDC 85248-140). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
For instant stimulation & focus during sports
Use
For instant stimulation & focus during sports
Warnings
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
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
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
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
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
If swallowed, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.
Directions
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
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
Alcohol, Cotton, Peppermint Oil.
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