Bisolvine Adult

Dosage form: liquid
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 100mg in 5mL, GUAIFENESIN 10mg in 5mL
Labeler: Pharmalab Enterprises Inc.
NDC Code: 14505-389

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active Ingredients (in each 5 mL)                  Purpose

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

Dextromethorphan.............................................. 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 under                     every 4 hours


Children 6 to under                               1 teaspoonful (5 mL)
12 years of age                                    every 4 hours


Children 2 to under                               1/2 teaspoonful (2.5 mL)
6 years of age                                      every 4 hours


Children under 2 years of age                Consult your doctor

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


BISOLVINE  ADULT
guaifenesin, dextromethorphan liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14505-389
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE100 mg  in 5 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
FD&C RED NO. 40 
METHYLPARABEN 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
SUCROSE 
Product Characteristics
Color    Score    
ShapeSize
FlavorSTRAWBERRY (Strawberry -Banana Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:14505-389-04120 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/18/2010
Labeler - Pharmalab Enterprises Inc. (174401088)
Registrant - Pharmalab Enterprises Inc. (174401088)
Establishment
NameAddressID/FEIOperations
Pharmalab Enterprises Inc.174401088manufacture

Revised: 08/2010
 
Pharmalab Enterprises Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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