Label: BENZEDREX 09-19-2014- propylhexedrine inhalant
- NDC Code(s): 0225-0610-23
- Packager: BF ASCHER AND CO INC
- 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.
Updated October 22, 2019
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- 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
- ASK DOCTOR
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INSTRUCTIONS FOR USE
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
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
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)