FDA Label for Bisolvine Children

View Indications, Usage & Precautions

Bisolvine Children 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.

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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