SPL v3
SPL
SPL Set ID 36b6ed08-4a98-6b31-e063-6394a90a6fb7
Route
RESPIRATORY (INHALATION)
Published
Effective Date 2025-06-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ammonia (15 g)
Inactive Ingredients
Alcohol Mint

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2025-06-04

Description

Ammonia (15%)


Medication Information

Warnings and Precautions

WARNINGS: For external use only. Avoid contact with skin, eyes, and mouth.

Indications and Usage

To prevent or treat fainting.

Dosage and Administration

DIRECTIONS: Hold bottle at least 6 inches from nose and inhale slowly no more than 1-2 times per use. Avoid repeated inhalationy

Description

Ammonia (15%)

Section 44425-7

OTHER INFORMATION: Store at room temperature away from light and moisture.

Section 50565-1

KEEP OUT OF REACH OF CHILDREN. If ingested, seek medical attention or contact Poison Control immediately.

Section 50566-9

STOP USE AND ASK A DOCTOR if symptoms occur.

Section 50567-7

INSTRUCTIONS:

1.Shake well before use.

2.Unscrew cap and hold at least 6 inches from nose.

3. Inhale slowly no more than 1-2 times per use.

4.Seal tightly and store in a dark, dry place at room temperature.

BEFORE USE:

Remove plastic seal, unscrew cap, and remove foil from mouth of bottle. Reseal lid after each use.

POTENCY PRESERVATION :

To maintain potency over time, always seal the lid tightly immediately after each use. Before each session, shake the bottle thoroughly to ensure optimal ammonia activation. For best experience, store the bottle in a dark, dry place at room temperature.

Section 50570-1

if allergic, pregnant or have respiratory conditions.

Section 51727-6

Alcohol, Mint Flavor.

Section 51945-4

Section 55105-1

Inhalant

Section 55106-9

Ammonia (15%)


Structured Label Content

Indications and Usage (34067-9)

To prevent or treat fainting.

Dosage and Administration (34068-7)

DIRECTIONS: Hold bottle at least 6 inches from nose and inhale slowly no more than 1-2 times per use. Avoid repeated inhalationy

Warnings and Precautions (34071-1)

WARNINGS: For external use only. Avoid contact with skin, eyes, and mouth.

Section 44425-7 (44425-7)

OTHER INFORMATION: Store at room temperature away from light and moisture.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN. If ingested, seek medical attention or contact Poison Control immediately.

Section 50566-9 (50566-9)

STOP USE AND ASK A DOCTOR if symptoms occur.

Section 50567-7 (50567-7)

INSTRUCTIONS:

1.Shake well before use.

2.Unscrew cap and hold at least 6 inches from nose.

3. Inhale slowly no more than 1-2 times per use.

4.Seal tightly and store in a dark, dry place at room temperature.

BEFORE USE:

Remove plastic seal, unscrew cap, and remove foil from mouth of bottle. Reseal lid after each use.

POTENCY PRESERVATION :

To maintain potency over time, always seal the lid tightly immediately after each use. Before each session, shake the bottle thoroughly to ensure optimal ammonia activation. For best experience, store the bottle in a dark, dry place at room temperature.

Section 50570-1 (50570-1)

if allergic, pregnant or have respiratory conditions.

Section 51727-6 (51727-6)

Alcohol, Mint Flavor.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Inhalant

Section 55106-9 (55106-9)

Ammonia (15%)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)