BENZEDREX 09-19-2014- propylhexedrine inhalant 
BF ASCHER AND CO INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Benzedrex

Active ingredient................. Purpose

Propylhexedrine 250 mg......Nasal decongestant

Uses

For the temporarily relief of nasal congestion due to a cold, hay fever, or other upper respiratory allergies (allergic rhinitis).

Uses

Temporarily relieves nasal congestion due to a cold, hay fever, or other upper respiratory allergies (allergic rhinitis).

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

Do not use this product for more than three days.

Stop use and consult a doctor if symptoms persist.

If pregnant or breast-feeding, ask a health professional before use.

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.

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

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

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 ingredients

lavender oil, menthol

Questions?

Call 1-800-324-1880, 7:30am - 4:00pm Central, Mon. - Fri., or visit us at www.bfascher.com

Benzedrex

BENZEDREX  09-19-2014
propylhexedrine inhalant
Product Information
Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0225-0610
Route of Administration NASAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROPYLHEXEDRINE (PROPYLHEXEDRINE) PROPYLHEXEDRINE 250 mg
Inactive Ingredients
Ingredient Name Strength
LAVENDER OIL  
MENTHOL  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0225-0610-23 1 in 1 INHALER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 09/19/2014
Labeler - BF ASCHER AND CO INC (003854403)

Revised: 9/2014
BF ASCHER AND CO INC