SPL v1
SPL
SPL Set ID 4575d816-b08f-13fb-e063-6294a90af3ba
Route
NASAL
Published
Effective Date 2025-12-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ammonia (150 mg)
Inactive Ingredients
Lavender Oil Lemon Oil Nutmeg Oil Fd&c Red No. 40 Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2025-12-08

Description

Ammonia (15%)...Inhalant

Purpose

Inhalant

Dosage and Administration

Hold inhalant away from face and crush between thumb and finger. Carefully approach crushed inhalant to nostrils of affected person.


Medication Information

Purpose

Inhalant

Dosage and Administration

Hold inhalant away from face and crush between thumb and finger. Carefully approach crushed inhalant to nostrils of affected person.

Description

Ammonia (15%)...Inhalant

Uses

Helps prevent or treat fainting.

Warnings

For external use only. Do not use if you have breathing problems such as asthma or emphysema. Stop use and ask a doctor if condition persists. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Do Not Use

Do not use if you have breathing problems such as asthma or emphysema.

Drug Facts Label

Active Ingredients

Ammonia (15%)...Inhalant

Inactive Ingredients

Inactive ingredients Alcohol USP, FD&C Red Dye # 40, Lavender Oil FCC, Lemon Oil FCC, Nutmeg Oil FCC, Purified Water USP.

Keep Out of Reach of Children.

Keep out of reach of children.


Structured Label Content

Uses

Helps prevent or treat fainting.

Purpose

Inhalant

Warnings

For external use only. Do not use if you have breathing problems such as asthma or emphysema. Stop use and ask a doctor if condition persists. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Do Not Use (Do not use)

Do not use if you have breathing problems such as asthma or emphysema.

Drug Facts Label

Active Ingredients

Ammonia (15%)...Inhalant

Inactive Ingredients (Inactive ingredients)

Inactive ingredients Alcohol USP, FD&C Red Dye # 40, Lavender Oil FCC, Lemon Oil FCC, Nutmeg Oil FCC, Purified Water USP.

Dosage and Administration

Hold inhalant away from face and crush between thumb and finger. Carefully approach crushed inhalant to nostrils of affected person.

Keep Out of Reach of Children. (Keep out of reach of children.)

Keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

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