85765-001 Smelling Salts

85765-001 Smelling Salts
SPL v2
SPL
SPL Set ID 36ceef42-c3ea-7302-e063-6394a90a94da
Route
INTRASINAL
Published
Effective Date 2025-06-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ammonia (15 g)
Inactive Ingredients
Aromatic-l-amino-acid Decarboxylase Solvent Blue 102 Alcohol Cotton Peppermint Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-05

Description

Ammonia 15%


Medication Information

Warnings and Precautions



For inhalation use only.

Do not ingest or apply to skin.

Avoid direct contact with eyes. lfcontact occurs, rinsethoroughly 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 useif discomfort occurs.

Possible side effects include nasal imitation, coughing, orshortness ofbreath. lfsymptoms persist, discontinue useand consult a doctor.

Indications and Usage

For the temporary stimulation of the senses to restore alertness.

Dosage and Administration



Hold bottle 10-15 cm (4-6 inches) from nostrils.

Inhale gently. Do not place directly inside the nostrils.

Do notinhale 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, lfsymptoms persist, consult ahealthcare professional!

Description

Ammonia 15%

Section 50565-1

Keep out ofreach ofchildren.lfswallowed, get medical

help or contact a Poison Control Center immediately at

1-800-222-1222

Section 50566-9

Stop use and ask a doctor ifirritation or rash occurs.

These may be signs of a serious condition.

Section 50567-7



Avoid contact with eyes, ears, and mouth.

lf 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 50570-1



lf you have respiratory conditions such as asthma oremphysema.

lf you have heart disease or high blood pressure.

If you are allergic to ammonia orstrong odors.

Section 51727-6

aromatic

solvent

Alcohol

Cotton

Peppermint Oil

Section 51945-4

Section 55105-1

Inhalant

Section 55106-9

Ammonia 15%


Structured Label Content

Indications and Usage (34067-9)

For the temporary stimulation of the senses to restore alertness.

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 notinhale 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, lfsymptoms persist, consult ahealthcare professional!

Warnings and Precautions (34071-1)



For inhalation use only.

Do not ingest or apply to skin.

Avoid direct contact with eyes. lfcontact occurs, rinsethoroughly 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 useif discomfort occurs.

Possible side effects include nasal imitation, coughing, orshortness ofbreath. lfsymptoms persist, discontinue useand consult a doctor.

Section 50565-1 (50565-1)

Keep out ofreach ofchildren.lfswallowed, get medical

help or contact a Poison Control Center immediately at

1-800-222-1222

Section 50566-9 (50566-9)

Stop use and ask a doctor ifirritation or rash occurs.

These may be signs of a serious condition.

Section 50567-7 (50567-7)



Avoid contact with eyes, ears, and mouth.

lf 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 50570-1 (50570-1)



lf you have respiratory conditions such as asthma oremphysema.

lf you have heart disease or high blood pressure.

If you are allergic to ammonia orstrong odors.

Section 51727-6 (51727-6)

aromatic

solvent

Alcohol

Cotton

Peppermint Oil

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)