SPL v1
SPL
SPL Set ID 3a87c99b-5516-fcc4-e063-6294a90a7b92
Route
RESPIRATORY (INHALATION)
Published
Effective Date 2025-07-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ammonia (15 g)
Inactive Ingredients
Alcohol Peppermint Oil Cotton

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-23

Description

Ammonia 15%


Medication Information

Description

Ammonia 15%

Use

For the temporary stimulation of the senses to restore alertness.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Section 51727-6

Alcohol, Cotton, Peppermint Oil.

Section 51945-4

Section 55105-1

Inhalant

Section 55106-9

Ammonia 15%

Stop Use

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

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.

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.

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.

Ask A Doctor

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

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

Use

For the temporary stimulation of the senses to restore alertness.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Section 51727-6 (51727-6)

Alcohol, Cotton, Peppermint Oil.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Inhalant

Section 55106-9 (55106-9)

Ammonia 15%

Stop Use

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

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.

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.

Do Not Use (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.

Ask A Doctor (ask a doctor)

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

Other Information (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

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