Benzedrex Nasal Decongestant

Drug Labeling and Warnings

Drug Details [pdf]

BENZEDREX NASAL DECONGESTANT- propylhexedrine inhalant 
Denison Pharmaceuticals LLC

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 Nasal Decongestant

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

label

label

BENZEDREX NASAL DECONGESTANT 
propylhexedrine inhalant
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0295-0100
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PROPYLHEXEDRINE (UNII: LQU92IU8LL) (PROPYLHEXEDRINE - UNII:LQU92IU8LL) PROPYLHEXEDRINE250 mg
Inactive Ingredients
Ingredient NameStrength
LAVENDER OIL (UNII: ZBP1YXW0H8)  
MENTHOL (UNII: L7T10EIP3A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0295-0100-521 in 1 INHALER; Type 0: Not a Combination Product01/21/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/21/2019
Labeler - Denison Pharmaceuticals LLC (001207208)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmaceuticals LLC001207208manufacture(0295-0100)

Revised: 1/2019
Document Id: 7ffa790e-a293-8015-e053-2a91aa0a94cb
Set id: 7ffa8df0-803c-b8d4-e053-2991aa0af7ea
Version: 1
Effective Time: 20190121