SPL v1
SPL
SPL Set ID 3ec301e9-f52c-6be4-e063-6394a90af9cd
Route
RESPIRATORY (INHALATION)
Published
Effective Date 2025-09-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-14

Description

Ammonia 15%


Medication Information

Warnings and Precautions

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

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.

Dosage and Administration

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

Ammonia 15%

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 For the temporary stimulation of the senses to restore alertness.

Section 55106-9

Ammonia 15%

Section 60561-8

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)

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.

Dosage and Administration (34068-7)

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)

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 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 For the temporary stimulation of the senses to restore alertness.

Section 55106-9 (55106-9)

Ammonia 15%

Section 60561-8 (60561-8)

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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