Biodesp
FDA Label NDC 45737-221

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 45737-221). 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 - Active Ingredient

Active Ingredients: (in each 5 mL tsp.)              Purpose

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

Dextromethorphan Hydrobromide 15 mg.................. Cough Suppressant

Phenylephrine HCl 5 mg.................................. Decongestant

Otc - Purpose

Uses
  • Indicated for the symptomatic relief of sinusitis, bronchitis, pharyngitis, relief of cough due to colds due minor upper respiratory infections

Warnings

Warnings

  • Do not exceed recommended dosage
  • A persistent cough may be a sign of a serious condition. If cough persists for more than a week, tends to reoccur or is accompanied by a fever, rash or persistent headache, consult a doctor
  • May cause or aggravate constipation
  • If nervousness, dizziness or sleeplessness occur, discontinue use and consult a doctor
  • If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor.

Otc - Do Not Use

Do not Use

  • For persistent cough such as occurs with smoking, asthma, chronic bronchitis, emphysema or where cough is accompanied by excessive phelgm (mucus), unless directed by a doctor
  • If you have a chronic pulmonary disease or shortness of breath, children who are taking other drugs, unless directed by a doctor. If nervousness, dizziness or sleeplessness occur, discontinue use and consult a doctor.
  • Do not give this product to a child who has
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes unless directed by a doctor.
    • If you are now 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.

    If you have
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • difficulty in urination due to the enlargement of the prostate gland unless directed by a doctor.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

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 2 teaspoonful (10 mL) every 6 hours

children 6 to under 12 years of age take 1 teaspoonful (5 mL) every 6 hours

children 2 to under 6 years of age take 1/2 teaspooful (2.5 mL) every 6 hours

children under 2 years of age  ask a doctor

Indications & Usage

Other information  store at room temperature 15°- 30°C (59° - 86°F).

Tamper Evident Feature: Do not use if seal under cap (or cello-band over cap) is torn, broken or missing.

Otc - Questions

Questions or comments? 1-305-403-3788
Manufactured For: Advanced Generic Corporation, Miami, FL 33166.
www.advancedgeneric.com

Inactive Ingredient

Inactive ingredients Glycerin, flavor, methylparaben, propylene glycol,
propylparaben, purified water, sodium citrate, sodium saccharin and sorbitol.

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