Biodesp
FDA Label NDC 45737-263

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 Biodesp (NDC 45737-263). 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, indications & usage, warnings, otc - keep out of reach of children, otc - pregnancy or breast feeding, dosage & administration, 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 5mL)                              Purpose

Dextromethorphan HBr, 10 mg ................................. Cough Suppressant

Guaifenesin, 100 mg ................................................ Expectorant

Phenylephrine HCl, 5 mg ...................................... Nasal Decongestant

Otc - Purpose

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Indications & Usage

Uses

  • temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis), or other upper respiratory allergies:
  • cough due to minor throat and bronchial irritation
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
  • nasal congestion
  • reduces swelling of nasal passages

Warnings

Warnings:

Do no exceed recommended dosage

  • A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur or is accompanied by a fever, rash or a persistent headache, consult a doctor

    • Do not use this product if you

    are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional condition. or for two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains a MAOI, ask a doctor or phamacist before taking thie product.

    Ask a doctor before use if you have

    • a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
    • high blood pressure
    • heart disease
    • thyroid disease
    • diabetes
    • difficulty in urincation due to enlargment of the prostate gland unless directed by a doctor

      • Stop use and ask a doctor if

      • nervousness, dizziness, or sleeplessness occur
        • if symptoms do not improve within 7 days or are accompanied by fever

          • Ask a doctor before use if you are taking sedatives or tranquilizers

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children.In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a doctor before use

Dosage & Administration

Directions: take every 4 hours, not to exceed 6 doses in 24 hours or as directed by a doctor.

AgeDose
Adults and children 12 years of age and over2 teaspoonfuls (10 mL) every 4 hours
Children 6 to under 12 years of age1 teaspoonful (5 mL) every 4 hours
Children under 6 years of age1/2 teaspoonful (2.5 mL) every 4 hours to consult a doctor

Inactive Ingredient

Inactive ingredients: citric acid, flavor, menthol, methylparaben, propylene glycol, propylparaben, pruified water, sodium citrate, and sucralose.

Otc - Questions

Questions or comments? 1-305-403-3788

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