Active Ingredients (In Each 10 Ml) Purpose
Dextromethorphan 20 mg.............................................. Cough Suppressant
Guaifenesin 200 mg ...................................................... Expectorant
Bisolvine
FDA Label NDC 53145-325
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 53145-325). 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 10 ml) purpose, purpose, uses, warnings, do not use:, otc - keep out of reach of children, otc - pregnancy or breast feeding, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
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, chronic brochitis 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.
Directions
Do not exceed 6 doses in 24 hours
| Age | Dose |
| Adults and Children 12 years of age and over | 2 teaspoonfuls (10 ml) every 4 hours |
| Children under 12 years of age | Do not use |
Inactive Ingredients
artificial strawberry-banana flavor, citric acid, fd&c red #40, glycerin, methyl paraben, propylene glycol, propylparaben, sucrose, water
Questions?
Questions? call 1-800-560-5523 M-F 9 AM to 4 PM Eastern.
Package Label.Principal Display Panel
Bisolvine Adult (Bisolvine)
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