FDA Label for Vapor Inhaler Levmetamfetamine Nasal Decongestant, Topcare Health
View Indications, Usage & Precautions
Vapor Inhaler Levmetamfetamine Nasal Decongestant, Topcare Health Product Label
The following document was submitted to the FDA by the labeler of this product Topco Associates Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
per inhaler:
Levmetamfetamine 50mg
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 Inhaler Label
NDC 36800-294-07
+TopCare®
health™
Vapor
Inhaler
LEVMETAMFETAMINE - NASAL DECONGESTANT
NET WT 0.007 OZ (198mg)
* Please review the disclaimer below.