FDA Label for Adult Bisolvine Adult

View Indications, Usage & Precautions

Adult Bisolvine Adult Product Label

The following document was submitted to the FDA by the labeler of this product Menper Distributors Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active Ingredients (in each 10 mL)                  Purpose

Guaifenesin 200 mg ................................................ Expectorant

Dextromethorphan HBr 20mg.............................................. 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.


Dosage & Administration



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



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


Inactive Ingredient



citric acid, fd&c red No.40, methyl paraben, propylene glycol, propylparaben, water, sucrose


* Please review the disclaimer below.