Label: CONEX- dexbrompheniramine maleate, pseudoephedrine liquid
- NDC Code(s): 54859-802-16
- Packager: Llorens Pharmaceutical International Division
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 27, 2024
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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 ifyou 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 ifyou 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 aretaking 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.
When using this product
- 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
Stop use and ask a doctor if
- 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 SODIUM CITRATE (UNII: 1Q73Q2JULR) WATER (UNII: 059QF0KO0R) SUCRALOSE (UNII: 96K6UQ3ZD4) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) MENTHOL (UNII: L7T10EIP3A) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54859-802-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/01/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 11/01/2007 Labeler - Llorens Pharmaceutical International Division (037342305)

