Label: CONEX- dexbrompheniramine maleate, pseudoephedrine liquid
- NDC Code(s): 54859-802-04
- Packager: Llorens Pharmaceutical International Division
- 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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- ACTIVE INGREDIENT
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PURPOSE
Uses:
- Temporarily relieves nasal congestion due to common cold, hay fever or other upper respiratory allergies
- Helps decongest sinus openings and sinus passages
- Reduces swelling of nasal passages, shrinks swollen membranes, and temporarily restores freer breathing through the nose
- Temporarily alleviates the following symtoms due to hay fever (allergic rhinitis) : runny nose, sneezing, itching of the nose or throat, itchy and watery eyes.
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WARNINGS
Warnings:
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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.
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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.
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DO NOT USE
Ask a doctor before use if you are taking sedatives or tranquilizers.
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disese
- diabetes
- glucoma
- difficulty in urination due to the enlargement of the prostate gland.
- do not exceed the recommended dosage
- excitability may occur, especially in children
- drowsiness may occur
- avoid alcoholic beverages
- alcohol, sedatives and tranquilizers may increase drowsiness
- use caution when driving a motor vehicle or operating machinery
- nervousness, dizziness or sleeplessness occur
- symptoms do not improve within 7 days or occur with a fever.
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
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DOSAGE & ADMINISTRATION
Directions: Do not exceed more than 4 doses in any 24-hour period or as directed by a doctor.
Age
Dose
Adults and children 12 years of age and over
take two teaspoonfuls (10 mL) every 4 to 6 hours
Children 6 to under 12 years of age
take one teaspoonful (5 mL) every 4 to 6 hours
Children under 6 years of age
ask a doctor
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INDICATIONS & USAGE
Other Information:
- Store at controlled room temperature 20-25 degree celcius ( 68-77 degree farenheit); excursions permitted to 15-30 degree clecius (59-86 degree farenheit) (See USP Controlled Room Temperture) Tamper evident by imprinted heat seal under cap
- Do not use if there is evidence of tampering
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WARNING: Phenylketonuric: Contains 13.5 mg of Phenylalanine per 5 mL (one teaspoonful) dose.
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CONEX
dexbrompheniramine maleate, pseudoephedrine liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54859-802 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) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) MENTHOL (UNII: L7T10EIP3A) METHYLPARABEN (UNII: A2I8C7HI9T) POTASSIUM CITRATE (UNII: EE90ONI6FF) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) 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:54859-802-04 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2007 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 11/01/2007 Labeler - Llorens Pharmaceutical International Division (037342305)