Label: BIO-CNEX- dexbrompheniramine maleate, pseudoephedrine hcl liquid
- NDC Code(s): 45737-239-16
- Packager: Advanced Generic Corporation
- 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 December 23, 2020
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
-
WARNINGS
Warnings
DO not use If you are taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if you are taking a prescription drug that contains an MAOI, ask your doctor or pharmacist before taking this product.
Ask a doctor before use if you are taking sedative or tranquilizers.
Ask a doctore before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- difficulty in urinations due to the enlargment of the prostate gland.
When using this product
- Do not exceed the recommended dosage
- excitability may occur, espicially in children
- drowsiness may occur
- avoid alcoholic beverages
- alcohol, sedatives and tranquilizers may increase drowsiness
- use cuation when driving a motor vehicle or operating machinery.
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- symptoms do not improve within 7 days or occur with fever.
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
- DOSAGE & ADMINISTRATION
-
INDICATIONS & USAGE
Uses
- Temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- helps decongest sinus opening and sinus passages
- reduces swelling of nasal pasages, shrinks swollen membranes, and temporarily restores freer breathing through the nose
- temporarily alleviates the following symptoms due to hay fever (allergic rhinitis)
- runny nose
- sneezing
- itching of the nose or throat
- itchy and watery eyes
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BIO-CNEX
dexbrompheniramine maleate, pseudoephedrine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45737-239 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP) DEXBROMPHENIRAMINE MALEATE 1 mg in 5 mL PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg in 5 mL Inactive Ingredients Ingredient Name Strength ASPARTAME (UNII: Z0H242BBR1) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) glycerin (UNII: PDC6A3C0OX) MENTHOL (UNII: L7T10EIP3A) METHYLPARABEN (UNII: A2I8C7HI9T) POTASSIUM CITRATE (UNII: EE90ONI6FF) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) Product Characteristics Color Score Shape Size Flavor CHERRY (cherry flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:45737-239-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 01/01/2017 Labeler - Advanced Generic Corporation (831762971)
