The following Structured Product Label (SPL) was submitted to the FDA by Menper Distributors Inc. for the product Adult Bisolvine (NDC 53145-323). 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, dosage & administration, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredients (in each 10 mL) Purpose
Guaifenesin 200 mg ................................................ Expectorant
Dextromethorphan HBr 20mg.............................................. 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 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.
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.
Keep out of reach of children
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.
Directions
* Do not exceed 6 doses in 24 hours
Age Dose
Adults and Children 2 teaspoonfuls (10 ml)
12 years of age and over every 4 hours
Children under 12 years of age Do not use
Other Information
Distributed by Menper Distributors, Inc.
6500 N.W. 35th Ave., Miami, Fl, 33147
www.menperdistributors.com
citric acid, fd&c red No.40, methyl paraben, propylene glycol, propylparaben, water, sucrose
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