Otc - Active Ingredient
Active Ingredient: Ammonia 15%
Ammonia Inhalants
FDA Label NDC 50332-0054
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hart Health for the product Ammonia Inhalants (NDC 50332-0054). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose:
Reflex Stimulant
Indications & Usage
Uses:
to aid in prevention and treatment of fainting
Warnings
Warnings:
For external use only
Flammable, keep away from heat or flame
Otc - Do Not Use
Do not use:
- if face is flush
- in or near the eyes
- if you have breathing problems such as asthma or emphysema
Otc - Stop Use
Stop use and ask a doctor if:
- patient is non-responsive
- condition lasts
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed get medical help or contact a Poison Control Center right away. 1-800-1222
Dosage & Administration
Adults and children 12 years of age and older:
- hold away from face and crush inhalant between fingers
- hold packet six inches from patient's nose
- gradually move inhalant closer until patient revives
- check strength frequently by holding near your own nose
- if necessary, use another when first is expended
- dispose of properly
Children under 12 years of age: ask a doctor
Inactive Ingredient
Inactive ingredients: alcohol USP, FD&C red dye #40, lavender oil FCC, lemon oil FCC, nutmeg oil FCC, purified water USP
* Please review the disclaimer below.
