Bio-cnex
FDA Label NDC 45737-239

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Advanced Generic Corporation for the product Bio-cnex (NDC 45737-239). 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, dosage & administration, indications & usage, inactive ingredient, 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 5 mL tsp.)                 Purpose

Dexbrompheniramine maleate 1 mg                            Antihistamine

Pseudoephedrine Hydrochloride 30 mg                         Nasal Decongestant

Otc - Purpose

Purpose

Antihistamine

Nasal Decongestant

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.

Ask a doctor before use if you are taking sedative or tranquilizers.

Ask a doctore before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • difficulty in urinations due to the enlargment of the prostate gland.

    • When using this product

    • Do not exceed the recommended dosage
    • excitability may occur, espicially in children
    • drowsiness may occur
    • avoid alcoholic beverages
    • alcohol, sedatives and tranquilizers may increase drowsiness
    • use cuation 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 fever.

Otc - Keep Out Of Reach Of Children

Keep out of 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 4 doses in 24 hours.

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

Uses

  • Temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • helps decongest sinus opening and sinus passages
  • reduces swelling of nasal pasages, 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
  • itchy and watery eyes

Inactive Ingredient

Inactive ingredients Aspertame, cherry flavor, citric acid, glycerine, menthol, methylparaben, potsassium citrate, potassium sorbate, propylene glycol, propylparaben and purified water.

Otc - Questions

Questions or comments?

1-305-403-3788

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Biocnex (Biocnex)

Biocnex (Biocnex)

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