BISOLVINE ALOE-MIEL- dextromethorphan, guaifenesin 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)

Dextromethorphan HBr 10mg............................ Cough Suppressant

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

Purpose

Cough Suppressant

Expectorant

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.

Do not exceed recommended dosage.

A persistant cough may be a sign of serious condition, if cough persist 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, chronic bronchitis, or emphysema or where 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

In case of accidental overdose, get medical help or contact a Poison Control Center right away. Keep out of reach of children

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use. 

Directions

• Do not exceed 6 doses in 24 hours

• Age: Dose
• Adults and children 12 years of age and more: 2 teaspoonfuls (30 ml) every 4 hours
• Children under 12 years of age: Consult your doctor

Inactive Ingredients

Aloe leaf extract, ascorbic acid, caramel color, cat's claw bark extract, corn syrup, DATEM, ethyl alcohol, eucalyptus oil, flavor, garlic bulb extract, ginger root extract, gum arabic, honey, menthol, methylparaben, onion bulb extract, peppermint leaf extract, polysorbate 80, potassium sorbate, propylene glycol, propylparaben, sodium benzoate, sucralose, sunflower oil, and water.

Questions or Coments?

Call 1-800-560-5223 M-F 9 AM to 4 PM Eastern.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BISOLVINE  ALOE-MIEL
dextromethorphan, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53145-402
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
Aloe (UNII: V5VD430YW9)
ascorbic acid (UNII: PQ6CK8PD0R)
CAT'S CLAW (UNII: 9060PRM18Q)
corn syrup (UNII: 9G5L16BK6N)
ALCOHOL (UNII: 3K9958V90M)
Eucalyptus oil (UNII: 2R04ONI662)
GARLIC (UNII: V1V998DC17)
GINGER (UNII: C5529G5JPQ)
ACACIA (UNII: 5C5403N26O)
honey (UNII: Y9H1V576FH)
menthol (UNII: L7T10EIP3A)
methylparaben (UNII: A2I8C7HI9T)
ONION (UNII: 492225Q21H)
PEPPERMINT (UNII: V95R5KMY2B)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
potassium sorbate (UNII: 1VPU26JZZ4)
propylene glycol (UNII: 6DC9Q167V3)
propylparaben (UNII: Z8IX2SC1OH)
sodium benzoate (UNII: OJ245FE5EU)
sucralose (UNII: 96K6UQ3ZD4)
sunflower oil (UNII: 3W1JG795YI)
water (UNII: 059QF0KO0R)
DIACETYLTARTARIC AND FATTY ACID ESTERS OF GLYCEROL (UNII: 248HN3Z28U)
CARAMEL (UNII: T9D99G2B1R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53145-402-06	1 in 1 CARTON	01/01/2019
1		180 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	01/01/2019

Labeler - MENPER DISTRIBUTORS INC. (101947166)