Active Ingredient
per inhaler:
Levmetamfetamine 50mg
Vapor Inhaler Inhalant
FDA Label NDC 36800-294
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Vapor Inhaler (NDC 36800-294). 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 active ingredient, purpose, use:, when using this product, otc - do not use, otc - stop use, other, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Nasal Decongestant
Use:
For temporary relief of nasal congestion due to
- the common cold
- hay fever or upper respiratory allergies
When Using This Product
- do not exceed recommended dosage
- temporary burning, stinging, sneezing, or increased nasal discharge may occur
- use of this container by more than one person may spread infection
Otc - Do Not Use
- do not use for more than 7 days
- use only as directed
- frequent or prolonged use may cause nasal congestion to recur or worsen
Otc - Stop Use
Stop use and ask a doctor if symptoms persist
Other
If pregnant or breast-feeding, ask a health professional before use.
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.
Directions
- the product delivers in each 800 ml of air 0.04 to 0.150 mg of levmetamfetamine
- do not use more often than every 2 hours
| adults and children 12 years of age and over | 2 inhalations in each nostril |
| children 6 to under 12 years of age (with adult supervision) | 1 inhalation in each nostril |
| children under 6 years of age | ask a doctor |
| children under 2 years of age | do not use |
Other Information
this inhaler is effective for a minimum of 3 months after first use • keep inhaler tightly closed • store at 59°-86° F (15°-30° C)
Inactive Ingredients
bornyl acetate, camphor, lavender oil, menthol, methyl salicylate
Principal Display Panel - 198 Mg Blister Pack Label
NDC 36800-294-07
+TopCare® health™
Vapor
Inhaler
OUR PHARMACISTS
RECOMMENDED
LEVMETAMFETAMINE - NASAL DECONGESTANT
Temporary Relief of Nasal
Congestion Due to:
• Colds • Hay Fever
• Upper Respiratory Allergies
NET WT 0.007 OZ (198mg)
Principal Display Panel (198 mg Blister Pack Label)
Principal Display Panel - 198 Mg Inhaler Label
NDC 36800-294-07
+TopCare®
health™
Vapor
Inhaler
LEVMETAMFETAMINE - NASAL DECONGESTANT
NET WT 0.007 OZ (198mg)
Principal Display Panel (198 mg Inhaler Label)
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