Otc - Active Ingredient
Active Ingredients (in each 5 mL tsp.)
Dexbrompheniramine Maleate, USP .......... 1 mg .................... Antihistamine
Pseudoephedrine HCL, USP ............ 30 mg ...................... Nasal Decongestant
Conex
FDA Label NDC 54859-802
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Llorens Pharmaceutical International Division for the product Conex (NDC 54859-802). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - keep out of reach of children, otc - pregnancy or breast feeding, dosage & administration, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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.
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.
Otc - 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. 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
- nervousness, dizziness or sleeplessness occur
- symptoms do not improve within 7 days or occur with a fever.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a Health Professional before use.
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 |
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
- WARNING: Phenylketonuric: Contains 13.5 mg of Phenylalanine per 5 mL (one teaspoonful) dose.
Inactive Ingredient
Inactive Ingredients: aspartame, cherry flavor, citric acid, glycerine, menthol, methylparaben, potassium citrate, potassium sorbate, propylene glycol, propylparaben and purified water.
Otc - Questions
Questions or Comments? 1-866-595-5598
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