Label: BENZEDREX 09-19-2014- propylhexedrine inhalant

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated October 22, 2019

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  • 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).

  • 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 use this product for more than three days.

  • ASK DOCTOR

    Stop use and consult a doctor if 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  09-19-2014
    propylhexedrine inhalant
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0225-0610
    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:0225-0610-231 in 1 INHALER; Type 0: Not a Combination Product09/19/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/19/2014
    Labeler - BF ASCHER AND CO INC (003854403)
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