Biospec
FDA Label NDC 45737-211

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 Biospec (NDC 45737-211). 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 - pregnancy or breast feeding, otc - keep out of reach of children, 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

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

Guaifenesin 25 mg .............................................. Expectorant

Otc - Purpose

Uses

  • temporarily relieves cough due to minor throat and bronchial irritations as may occur with a cold
    • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warnings

Warnings
  • Do not exceed recommended dosage.
    • Do not use 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.
      • Ask a doctor before use if you have
      • Cough that occurs with too much phlegm (mucus)
        • Cough that lasts or is such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.

Otc - Do Not Use

Stop use and ask a doctor if
  • you get nervous, dizzy or sleepless
  • symptoms do not get better within 7 days or accompanied by fever
  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Dosage & Administration

Directions Do not take more than 6 doses in any 24-hour period, unless directed by a physician

adults and children 12 years and over, 1 teaspoonfuls (5 ml) every 4 hours

children 6 years to under 12 years, 1/2 teaspoonful (2.5 ml) every 4 hours

children 4 to 6 years, 1/4 teaspoonful (1.25 ml) every 4 hours

children under 4 years of age, consult 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.

Inactive Ingredient

Inactive ingredients Cherry Flavor, Glycerin, Menthol, Potassium Guaiacol Sulfonate,
Sodium Benzoate, Sodium Citrate, Sodium Saccharin, Water.

Otc - Questions

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

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Biospecdmxlabel (Biospecdmxlabel)

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