Bisolvine
FDA Label NDC 14505-488

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pharmalab Enterprises Inc. for the product Bisolvine (NDC 14505-488). 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, otc - pregnancy or breast feeding, other information, directions, 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)                  Purpose

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

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

Otc - Purpose

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

Warnings: Do not exceed recommended dosage.

A persistent or chronic 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.

Otc - Do Not Use

Do not use:

    * this product for persistent or chronic cough, such as occurs with smoking, asthma, or emphysema or if 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 - Keep Out Of Reach Of Children

Keep out of reach of children

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Other Information

Other Information

  •    store this product between (15 to 30 C) (59 to 86 C)
    • Distributed by Menper Distributors, Inc.
         6500 N.W. 35th Ave., Miami, Fl, 33147
               www.menperdistributors.com

Directions

Directions  


  • Do not exceed 6 doses in 24 hours

    • Age                                                                    Dose

    Children 6 to under                               1 tablespoonful (15 mL)
    12 years of age                                    every 4 hours


    Children 2 to under                               1/2 tablespoonful (7.5 mL)
    6 years of age                                      every 4 hours


    Children under 2 years of age                Consult your doctor

Package Label.Principal Display Panel

Bisolvinechilelabel (Bisolvinechild)

Bisolvinechilelabel (Bisolvinechild)

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