Bisolvine Liquid
FDA Label NDC 53145-322

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 53145-322). 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, warnings:, do not:, keep out of reach of children, directions, other safety information, 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)

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

Dextromethorphan.............................................. Cough Suppressant

Purpose

Expectorant

Cough Suppressant

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.

Warnings:

Do not exceed recommended dosage.

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

Do Not:

  • give this product for persistent or chronic cough, such as occurs with asthma, or emphysema or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor.
  • use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Keep Out Of Reach Of Children

In case of accidental overdose, seek professional assisstance or contact a Poison Control Center immediately.

Directions

Age

 Dose
 Children 6 to under 12 years of age 1 teaspoonful (15 mL) every 4 hours
 Children 2 to under 6 years of age 1/2 teaspoonful (7.5 mL) every 4 hours
 Children under 2 years of age Consult your doctor

Other Safety Information

store this product between 15° to 30° C (59°-86° F)

Inactive Ingredient

artificial strawberryt-banana flavor, citric acid, fd&c red #40, glycerin, methylparaben, propylene glycol, propylparaben, puridied water, sucrose.

Questions?

1-800-560-5223 M-F 9 AM to 4 PM Eastern.

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