Bio-s-pres
FDA Label NDC 45737-230

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-s-pres (NDC 45737-230). 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, dosage & administration, inactive ingredient, otc - questions, 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 1mL)                   Purpose

Dextromethorphan HBr, 5 mg ................................. Cough Suppressant

Guaifenesin, 50 mg ................................................ Expectorant

Phenylephrine HCl, 2.5 mg ...................................... Nasal Decongestant



Otc - Purpose

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Warnings

Warnings:


Do not exceed recommended dosage.

  • If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor.
  • If symptoms do not improve within 7 days or accompanied by fever, consult a doctor.

Otc - Do Not Use

  • Do not use this product:for persistent or chronic cough such as occurs with asthma, or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor.
  • in a child who is taking a prescription Monoaminooxidase Inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for two weeks after stopping the MAOI drug; If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
  • Do not give this product to child who has heart disease, high blood pressure, thyroid disease, or diabetes, unless directed by a doctor.
  • Stop use and ask a doctor:
  • A persistent cough may be a sign of a serious condition;
  • If cough persists for more than one week, tend to recur, or is accompanied by fever, rash or persistent headache, consult a doctor.

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 right away.

Dosage & Administration

Directions:Do not exceed more than 6 doses in any 24-hour period. Measure with the dosage device provided. Do not use with any other device.

Age
Dose
Children 2 to under 6 years of age
1 mL every 4 hours
Children under 2 years of age
Consult a doctor

Inactive Ingredient

Inactive ingredients:Artificial  and natural Cherry Flavor, Citric Acid, FD and C Red No. 40, Glycerin, Methyl Paraben (as preservative), Propylene Glycol, Propylparaben (as preservative), Purified Water, sodium citrate, Sand sucralose

Otc - Questions

Questions or comments? 1-305-403-3788

Indications & Usage

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
temporarily relieves nasal congestion due to hay fever or other upper respiratory allergies (allergic rhinitis) and cough due to minor throat and bronchial irritation as may occur with the common cold.

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