Conex Tablet
FDA Label NDC 54859-702

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 Pharmaceuticals International Division for the product Conex (NDC 54859-702). 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 - keep out of reach of children, otc - pregnancy or breast feeding, otc - do not use, 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 - Active Ingredient

Active Ingredients (in each film coated tablet)                                               Purpose

Dexbrompheniramine Maleate, USP ................ 2 mg ................................... Antihistamine
Pseudeophedrine 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

Package Label.Principal Display Panel

Conextablabel (Conextabs)

Conextablabel (Conextabs)

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