Otc - Active Ingredient
Active ingredient................. Purpose
Propylhexedrine 175 mg......Nasal decongestant
Benzedrex Inhalant
FDA Label NDC 0225-0611
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bf Ascher And Co Inc for the product Benzedrex (NDC 0225-0611). 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, indications & usage, otc - purpose, warnings, otc - do not use, otc - ask doctor, otc - pregnancy or breast feeding, 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
Indications & Usage
Uses
For the temporarily relief of nasal congestion due to a cold, hay fever, or other upper respiratory allergies (allergic rhinitis).
Otc - Purpose
Uses
Temporarily relieves nasal congestion due to a cold, hay fever, or other upper respiratory allergies (allergic rhinitis).
Warnings
Warnings
- Do not exceed recommended dosage.
- This product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge.
- The use of this container by more than one person may spread infection.
- Use only as directed.
- Frequent or prolonged use may cause nasal congestion to recur or worsen.
- Ill effects may result if taken internally
Otc - Do Not Use
Do not usethis product for more than three days.
Otc - Ask Doctor
Stop use and consult a doctorif symptoms persist.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding,ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep this and all drugs out of reach of children.In case of overdose or ingestion of contents, get medical help or contact a poison control center immediately.
Dosage & Administration
Directions
- adults and children 6 to 12 years of age (with adult supervision): two inhalations in each nostril not more than every two hours.
- children under 6 years of age: consult a doctor
Instructions For Use
Directions
- adults and children 6 to 12 years of age (with adult supervision): two inhalations in each nostril not more than every two hours.
- children under 6 years of age: consult a doctor
Storage And Handling
Other information
- store at 59°-86° F (15°-30° C)
- keep inhaler tightly closed
- mfd. in USA for B.F. Ascher & Co., Inc.
- this inhaler is effective for a minimum of 3 months after first use
Inactive Ingredient
Inactive ingredients
lavender oil, menthol
Otc - Questions
Questions?
Call 1-800-324-1880, 7:30am - 4:00pm Central, Mon. - Fri., or visit us at www.bfascher.com
Package Label.Principal Display Panel
Benzedrex (Benzedrex)
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