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Name:Bisolvineadult
Manufacturer:Pharmalab Enterprises Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

BISOLVINE ADULT - dextromethorphan hydrobromide and guaifenesin liquid 
Pharmalab Enterprises Inc.

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.

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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


BisolvineAdultLabel


BISOLVINE  ADULT
guaifenesin, dextromethorphan liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:14505-389
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 100 mg  in 5 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 10 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE  
FD&C RED NO. 40  
METHYLPARABEN  
PROPYLENE GLYCOL  
PROPYLPARABEN  
WATER  
SUCROSE  
Product Characteristics
Color      Score     
Shape Size
Flavor STRAWBERRY (Strawberry -Banana Flavor) Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:14505-389-04 120 mL in 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 02/18/2010

Labeler - Pharmalab Enterprises Inc. (174401088)
Registrant - Pharmalab Enterprises Inc. (174401088)
Establishment
Name Address ID/FEI Operations
Pharmalab Enterprises Inc. 174401088 manufacture

Revised: 08/2010 Pharmalab Enterprises Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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