Bisolvine Liquid
FDA Label NDC 53145-402

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Menper Distributors Inc. for the product Bisolvine (NDC 53145-402). 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 active ingredients (in each 15 ml), purpose, uses, do not exceed recommended dosage., do not use:, otc - pregnancy or breast feeding, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each 15 Ml)

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

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

Purpose

Cough Suppressant

Expectorant

Uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold and helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

Do Not Exceed Recommended Dosage.

A persistant cough may be a sign of serious condition, if cough persist for more than one week, tends to recur, or is accompanied by fever, rash or persistent headache, consult a doctor.

Do Not Use:

* this product for 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.
* 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 your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Otc - Pregnancy Or Breast Feeding

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

Directions

  • Do not exceed 6 doses in 24 hours
    •  Age Dose
     Adults and children 12 years of age and more 2 teaspoonfuls (30 ml) every 4 hours
     Children under 12 years of age Consult your doctor

Inactive Ingredients

Aloe leaf extract, ascorbic acid, caramel color, cat's claw bark extract, corn syrup, DATEM, ethyl alcohol, eucalyptus oil, flavor, garlic bulb extract, ginger root extract, gum arabic, honey, menthol, methylparaben, onion bulb extract, peppermint leaf extract, polysorbate 80, potassium sorbate, propylene glycol, propylparaben, sodium benzoate, sucralose, sunflower oil, and water.

Questions Or Coments?

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