SPL v3
SPL
SPL Set ID 377fa82a-dcbe-9ab6-e063-6394a90a6384
Route
RESPIRATORY (INHALATION)
Published
Effective Date 2025-06-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-14
Description

Ammonia 15%

Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

To prevent or treat fainang.

Dosage and Administration

Hold bottle 10-15 cm from nostrils and inhale slowly 1-2 times.

Description

Ammonia 15%

Section 44425-7

Store in a cool, dry place inaccessible to children.

Section 50565-1

KEEP OUT OF REACH OF CHILDREN: Store in a cool, dry place inaccessible to children. Swallowing may cause poisoning. If swallowed, seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222).

Section 50566-9

Stop use and ask a doctor if allergic reaction (rash, swelling) or persistent irritation occurs.

Section 50567-7

Avoid repeated inhalation. Do not use more than 2 times per application.

Section 50570-1

Do not use if you have respiratory conditions such as asthma or emphysema. Discontinue use and consult a doctor if symptoms persist

Section 51727-6

Alcohol, Cotton, Peppermint Flavour

Section 51945-4

Section 55105-1

Inhalants

Section 55106-9

Ammonia 15%

Structured Label Content

Indications and Usage (34067-9)

To prevent or treat fainang.

Dosage and Administration (34068-7)

Hold bottle 10-15 cm from nostrils and inhale slowly 1-2 times.

Warnings and Precautions (34071-1)

For external use only.

Section 44425-7 (44425-7)

Store in a cool, dry place inaccessible to children.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN: Store in a cool, dry place inaccessible to children. Swallowing may cause poisoning. If swallowed, seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222).

Section 50566-9 (50566-9)

Stop use and ask a doctor if allergic reaction (rash, swelling) or persistent irritation occurs.

Section 50567-7 (50567-7)

Avoid repeated inhalation. Do not use more than 2 times per application.

Section 50570-1 (50570-1)

Do not use if you have respiratory conditions such as asthma or emphysema. Discontinue use and consult a doctor if symptoms persist

Section 51727-6 (51727-6)

Alcohol, Cotton, Peppermint Flavour

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Inhalants

Section 55106-9 (55106-9)

Ammonia 15%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:32.938390 · Updated: 2026-03-14T23:09:23.715399