Label: BENZEDREX- propylhexedrine inhalant

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 5, 2024

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

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

    Propylhexedrine 175 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).

  • 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
  • DO NOT USE

    Do not usethis product for more than three days.

  • ASK DOCTOR

    Stop use and consult a doctorif symptoms persist.

  • PREGNANCY OR BREAST FEEDING

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

  • 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

  • QUESTIONS

    Questions?

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

  • PRINCIPAL DISPLAY PANEL

    Benzedrex

  • INGREDIENTS AND APPEARANCE
    BENZEDREX 
    propylhexedrine inhalant
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0225-0611
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PROPYLHEXEDRINE (UNII: LQU92IU8LL) (PROPYLHEXEDRINE - UNII:LQU92IU8LL) PROPYLHEXEDRINE175 mg
    Inactive Ingredients
    Ingredient NameStrength
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    MENTHOL (UNII: L7T10EIP3A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0225-0611-231 in 1 INHALER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)06/23/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01206/23/2023
    Labeler - BF ASCHER AND CO INC (003854403)