BIGHERO SMELLING SALTS- ammonia 15% smelling salts inhalant

Bighero SMELLING SALTS by

Drug Labeling and Warnings

Bighero SMELLING SALTS by is a Otc medication manufactured, distributed, or labeled by Jiangxi Hemei Pharmaceutical Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ammonia 15%

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

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

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Ask Doctor

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep Oot 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.

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BIGHERO SMELLING SALTS 
ammonia 15% smelling salts inhalant

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84010-088
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X)	AMMONIA	15 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
PEPPERMINT OIL (UNII: AV092KU4JH)
COTTON (UNII: 70LDW53ROO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84010-088-01	40 g in 1 BOTTLE; Type 0: Not a Combination Product	03/13/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M011	03/13/2025

Labeler - Jiangxi Hemei Pharmaceutical Co., Ltd (724892056)

Establishment
Name	Address	ID/FEI	Business Operations
Jiangxi Hemei Pharmaceutical Co., Ltd		724892056	manufacture(84010-088)