SPL v1
SPL
SPL Set ID 33a54465-324a-9f07-e063-6394a90a6040
Route
RESPIRATORY (INHALATION)
Published
Effective Date 2025-04-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ammonia (15 g)
Inactive Ingredients
Peppermint Oil Ammonium Carbonate Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-26

Description

Drug Facts


Medication Information

Warnings and Precautions

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.

Indications and Usage

Use

For the temporary stimulation of the senses to restorealertness.

Dosage and Administration

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.

Description

Drug Facts

Section 50565-1

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.

Section 50566-9

Stop Use

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

Section 50567-7

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.

Section 50569-3

Ask Doctor

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

Section 50570-1

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.

Section 51727-6

Inactive ingredients

Alcohol, Ammonium Carbonate, Peppermint Oil.

Section 51945-4

Drug Facts

Section 55105-1

Purpose

Inhalant

Section 55106-9

Active Ingredient

Ammonia 15%

Section 60561-8

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 .


Structured Label Content

Indications and Usage (34067-9)

Use

For the temporary stimulation of the senses to restorealertness.

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

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.

Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

Stop Use

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

Section 50567-7 (50567-7)

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.

Section 50569-3 (50569-3)

Ask Doctor

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

Section 50570-1 (50570-1)

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.

Section 51727-6 (51727-6)

Inactive ingredients

Alcohol, Ammonium Carbonate, Peppermint Oil.

Section 51945-4 (51945-4)

Drug Facts

Section 55105-1 (55105-1)

Purpose

Inhalant

Section 55106-9 (55106-9)

Active Ingredient

Ammonia 15%

Section 60561-8 (60561-8)

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 .


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)