BISOLVINE CHILDREN- guaifenesin, dextromethorphan liquid

Bisolvine by

Drug Labeling and Warnings

Bisolvine by is a Otc medication manufactured, distributed, or labeled by MENPER DISTRIBUTORS INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BISOLVINE  CHILDREN
guaifenesin, dextromethorphan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53145-322
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SUCROSE (UNII: C151H8M554)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	STRAWBERRY (STRAWBERRY-BANANA)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53145-322-04	1 in 1 CARTON	01/18/2010
1		120 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/18/2010

Labeler - MENPER DISTRIBUTORS INC. (101947166)