FDA Label for Conex
View Indications, Usage & Precautions
Conex Product Label
The following document was submitted to the FDA by the labeler of this product Llorens Pharmaceuticals International Division. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active Ingredients (in each film coated tablet) Purpose
Dexbrompheniramine Maleate, USP ................ 2 mg ................................... AntihistaminePseudeophedrine HCl, USP .................... 60 mg ......................................... Nasal Decogestant
Otc - Purpose
Uses
- Temporarily relieves nasal congestion due to the 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 symptoms due to hay fever (allergic rhinitis): runny nose, sneezing, itching of the nose or throat, itching and watery eyes.
Warnings
Warnings:
Ask a doctor before you use if you are- taking sedatives or tranquilizers. Ask your doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- 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 doctor if
- nervousness, dizziness or sleepiness occur
- symptoms do not improve withing 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.
Otc - Do Not Use
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 MAOI;
ask your doctor or pharmacist before taking this product.
Dosage & Administration
Directions; Do not exceed more than 4 tablets in any 24-hour period or as directed by a doctor.
| Adults and children 12 years of age and over | Take one tablet every 4 to 6 hours |
| Children 6 to under 12 years of age | 1/2 tablet 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 celsius (68 - 77 degree fahrenheit); excursions permitted to
15 - 30 degree celsius ( 59 - 86 degree fahrenheit) [ See USP Controlled Room Temperature] Tamper evident by imprinted heat seal
under cap. Do not use if there is evidence of tampering.
Inactive Ingredient
Inactive Ingredients: Dicalcium Phosphate, Microcrystalline Cellulose, Magnesium Stearate, Sodium Starch Glycolate type B, Purified Water, Red iron Oxide, Yellow Iron Oxide, Titanium Dioxide.
Otc - Questions
Questions or Comments? 1-866-595-5598
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