Biospec
FDA Label NDC 45737-264

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 45737-264). 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 - do not use, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, 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 HBr 10 mg.................. Cough Suppressant

Guaifenesin 187 mg .............................................. Expectorant

Otc - Purpose

Purpose

cough suppressant

expectorant

Indications & Usage

Uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with cold

helps loosen phlegm (mucus) and thin bronchial secretions to make cough 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

  • 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. In case of overdose, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions Do not take more than 8 teaspoonfuls in any 24-hour period

 adults and children 12 years of age and over take 2 teaspoonfuls (10 mL) every 4 hours
 children 6 years to under 12 years of agetake 1 teaspoonful every 4 hours 
 children 2 years to under 6 years of age take 1/2 teaspoonful every 4 hours
 children under 2 years of ageconsult a doctor 

Other Safety Information

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 citric acid, glycerin, methylparaben, natural and artificial flavors, potassium sorbate, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

Otc - Questions

Questions or comments? 1-305-403-3788

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Biospecdmx264 (Biospecdmx264)

Biospecdmx264 (Biospecdmx264)

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