Active Ingredient
Ammonia 15%
The following Structured Product Label (SPL) was submitted to the FDA by Jiangxi Yudexi Pharmaceutical Co., Ltd for the product Unikinesys Smelling Salts (NDC 85248-197). 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.
Ammonia 15%
Inhalant
For the temporary stimulation of the senses to restore alertness.
For inhalation use only.
Do not ingest or apply to skin.
Avoid direct contact with eyes.
If contact occurs, rinse thoroughly with water for 15 minutes.
Use only as directed. Misuse may be harmful.
Use in a well-ventilated area.
Do not use in enclosed spaces.
Prolonged exposure may cause irritation.
Discontinue use if discomfort occurs.
Possible side effects include nasal irritation, coughing, or shortness of breath.
If symptoms persist, discontinue use and consult a doctor.
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.
Avoid contact with eyes, ears, and mouth.
If product gets into eyes, rinse thoroughly with water for 15 minutes.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.
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.
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 .
Alcohol, Ammonium Carbonate , Peppermint Oil.
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