Benzedrex

Benzedrex
SPL v2
SPL
SPL Set ID 00d8c237-3eee-1d9f-e063-6394a90aeb86
Route
NASAL
Published
Effective Date 2014-09-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Propylhexedrine (175 mg)
Inactive Ingredients
Lavender Oil Menthol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-06-23

Description

Active ingredient................. Purpose Propylhexedrine 175 mg......Nasal decongestant


Medication Information

Warnings and Precautions

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
Indications and Usage

Uses

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

Dosage and 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
Description

Active ingredient................. Purpose Propylhexedrine 175 mg......Nasal decongestant

Section 44425-7

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
Section 50565-1

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.

Section 50569-3

Stop use and consult a doctorif symptoms persist.

Section 50570-1

Do not usethis product for more than three days.

Section 51727-6

Inactive ingredients

lavender oil, menthol

Section 51945-4

Section 53413-1

Questions?

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

Section 53414-9

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

Section 55105-1

Uses



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

Section 55106-9

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



Propylhexedrine 175 mg......Nasal decongestant

Section 59845-8

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

Structured Label Content

Indications and Usage (34067-9)

Uses

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

Dosage and Administration (34068-7)

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
Warnings and Precautions (34071-1)

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
Section 44425-7 (44425-7)

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
Section 50565-1 (50565-1)

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.

Section 50569-3 (50569-3)

Stop use and consult a doctorif symptoms persist.

Section 50570-1 (50570-1)

Do not usethis product for more than three days.

Section 51727-6 (51727-6)

Inactive ingredients

lavender oil, menthol

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions?

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

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Uses



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

Section 55106-9 (55106-9)

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



Propylhexedrine 175 mg......Nasal decongestant

Section 59845-8 (59845-8)

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

Advanced Ingredient Data


Raw Label Data

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