Bighero SMELLING SALTS
84010-128
3619283a-3444-f876-e063-6394a90a4f2f
HUMAN OTC DRUG LABEL
May 27, 2025
Jiangxi Hemei Pharmaceutical Co., Ltd
DUNS: 724892056
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ammonia 15% SMELLING SALTS
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (4)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
Use
For the temporary stimulation of the senses to restore alertness.
OTC - ACTIVE INGREDIENT SECTION
Active Ingredient
Ammonia 15%
OTC - PURPOSE SECTION
Purpose
Inhalant
WARNINGS SECTION
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.
OTC - DO NOT USE SECTION
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.
OTC - WHEN USING SECTION
When Using
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
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
OTC - ASK DOCTOR SECTION
Ask Doctor
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 SECTION
Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.
DOSAGE & ADMINISTRATION SECTION
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.
STORAGE AND HANDLING SECTION
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 INGREDIENT SECTION
Inactive ingredients
Alcohol, Cotton, Peppermint Oil.