Otc - Active Ingredient
Ammonia 15%
Smelling Salts Inhalant
FDA Label NDC 87711-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hodayfa Abu Alkian for the product Smelling Salts (NDC 87711-001). 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 otc - active ingredient, otc - purpose, use, warnings, do not use, when using this product, otc - stop use section, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Inhalant
Use
For the temporary stimulation of the senses to restore alertness.
Warnings
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.
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 This Product
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.
Otc - Stop Use Section
Stop use and ask a doctor if irritation or rash occurs.These may be signs of a serious condition.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately at1-800-222-1222.
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 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℃ (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.
Package Label.Principal Display Panel
87711-001-01 (87711 001 01)
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