BISOLVINE CHILD- guaifenesin, dextromethorphan liquid

Bisolvine by

Drug Labeling and Warnings

Bisolvine by is a Otc medication manufactured, distributed, or labeled by Pharmalab Enterprises Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients (in each 5 mL)                  Purpose

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

Dextromethorphan.............................................. Cough Suppressant

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.

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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

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.

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

Directions

Directions  

• Do not exceed 6 doses in 24 hours

Age                                                                    Dose

Children 6 to under                               1 tablespoonful (15 mL)
12 years of age                                    every 4 hours


Children 2 to under                               1/2 tablespoonful (7.5 mL)
6 years of age                                      every 4 hours


Children under 2 years of age                Consult your doctor

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BISOLVINE  CHILD
guaifenesin, dextromethorphan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14505-488
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	100 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	10 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color		Score
Shape		Size
Flavor	STRAWBERRY (Strawberry -Banana Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14505-488-04	120 mL in 1 BOTTLE, PLASTIC

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	Business Operations
Pharmalab Enterprises Inc.		174401088	manufacture