FDA Label for Benzedrex 09-19-2014
View Indications, Usage & Precautions
- 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
- DOSAGE & ADMINISTRATION
- INSTRUCTIONS FOR USE
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Benzedrex 09-19-2014 Product Label
The following document was submitted to the FDA by the labeler of this product Bf Ascher And Co Inc. 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.
Otc - Active Ingredient
Active ingredient................. Purpose
Propylhexedrine 250 mg......Nasal decongestant
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 use this product for more than three days.
Otc - Ask Doctor
Stop use and consult a doctor if 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
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