BENZEDREX 09-19-2014- propylhexedrine inhalant

BENZEDREX by

Drug Labeling and Warnings

BENZEDREX by is a Otc medication manufactured, distributed, or labeled by BF ASCHER AND CO INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

BENZEDREX  09-19-2014
propylhexedrine inhalant

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0225-0610
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PROPYLHEXEDRINE (UNII: LQU92IU8LL) (PROPYLHEXEDRINE - UNII:LQU92IU8LL)	PROPYLHEXEDRINE	250 mg

Inactive Ingredients
Ingredient Name	Strength
LAVENDER OIL (UNII: ZBP1YXW0H8)
MENTHOL (UNII: L7T10EIP3A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0225-0610-23	1 in 1 INHALER; Type 0: Not a Combination Product	09/19/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/19/2014

Labeler - BF ASCHER AND CO INC (003854403)