BENZEDREX

Manufacturer
BF ASCHER AND CO INC
Effective date
2024-12-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:40:43

Label at a glance#

ProductBENZEDREX
Active ingredientPROPYLHEXEDRINE
Label structure14 sections

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

Propylhexedrine 175 mg......Nasal decongestant

INDICATIONS & USAGE SECTION

Uses

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

OTC - PURPOSE SECTION

Uses

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

WARNINGS SECTION

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 SECTION

Do not usethis product for more than three days.

OTC - ASK DOCTOR SECTION

Stop use and consult a doctorif symptoms persist.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 SECTION

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 SECTION

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 SECTION

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 SECTION

Inactive ingredients

lavender oil, menthol

OTC - QUESTIONS SECTION

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

BenzedrexBenzedrex

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0225-0611-23BENZEDREX1 in 1 INHALERINHALANT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0225-0611BENZEDREX (PROPYLHEXEDRINE) INHALANT [BF ASCHER AND CO INC]2Current NDC, 1 package rows20241208_00d8c237-3eee-1d9f-e063-6394a90aeb86.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0225-06110225-0611-23

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
LAVENDER OILZBP1YXW0H8IACT
MENTHOLL7T10EIP3AIACT
PROPYLHEXEDRINELQU92IU8LLACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BENZEDREXPROPYLHEXEDRINEBF ASCHER AND CO INC00d8c237-3eee-1d9f-e063-6394a90aeb862024-12-05WarningsExact identifier
ndc (package): 0225-0611-23
ndc (product): 0225-0611
ndc11 (package): 00225061123
spl id: 2888acff-4fa4-a9d7-e063-6394a90a7eda
spl set id: 00d8c237-3eee-1d9f-e063-6394a90aeb86

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.