BRONCOCHEM MAXIMUM COUGH KIDS- dextromethorphan hbr-guaifenesin syrup

BRONCOCHEM by

Drug Labeling and Warnings

BRONCOCHEM by is a Otc medication manufactured, distributed, or labeled by LABORATORIO MAGNACHEM INTERNATIONAL SRL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Warnings

Do not Use

If you are now taking a prescription monoamine oxidase inhibitor (MAOI) or two weeks after stopping the MAOI drug (certain drugs for depression, psychiatric or emotional conditions may contain MAOI), if you are uncertain whether your prescription contains MAOI ask a doctor or pharmacist before taking this product.

Uses

Temporarily relieves coug due to minor throat and Bronchial irritation occurring with common cold.  Helps loosen phlegm (mucus) and dilute bronchial secretions to make cough more productive.

Active Ingredients

Guaifenesin........................100.00mg

Dextromethorphan HBr........10.00mg

Ask a doctor before use if your kid have

Cough that occurs with too much phlegm (mucus)

Persistent or chronic cough, asthma or emphysema

If your kid is allergic to any other component of this formula

Stop use and ask a doctor if

Symptoms last more than 5 days

Cough occurs with fever, rash or persistent headache, this could be signs of a serious condition

keep out of the reach od children

Keep out of the reach of children

Overdose Warnigs

In case of accidental overdose, seek professional assistance or contact a poison control center immediately

Directions

Take only as directed, for your convinience a dosage spoon is provided. Do not excees 4 doses in a 24 hour period

Children from 6 to 12 years------15mL or cc every 6 hours

Children from 2 to 6 years-------7.5mL or ccevery 6 hours

Children under 2 years, ask your doctor

Other Information

Store al 66-77

Inactive Ingredients

Propylene glycol, Glycerin, Sorbitol 70%, Povidone, Sodium Citrate Dihydrate, Sodium Chloride,

Green color, White Vanilla Flavor, Aloe Vera, Methy Paraben USP, Propil Paraben USP. Peppermint Flavor, Bubble  Gum Flavor, Purified Water

Quiestions

1-561-338-5221 or visit us at www.broncochem.com

Purpose

Guaifenesin........................Expectorant

Dextromethorphan HBr.........Antotussive

Package Label Principal Display Panel

Package Label Principal Display Panel

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BRONCOCHEM  MAXIMUM COUGH KIDS
dextromethorphan hbr-guaifenesin syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65131-180
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
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	2.25 mL  in 15 mL
GLYCERIN (UNII: PDC6A3C0OX)	2.25 mL  in 15 mL
SORBITOL (UNII: 506T60A25R)	2.25 mL  in 15 mL
SUCRALOSE (UNII: 96K6UQ3ZD4)	15 mg  in 15 mL
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)	45 mg  in 15 mL
DISODIUM HEDTA (UNII: KME849MC7A)	1.35 mg  in 15 mL
POVIDONE K90 (UNII: RDH86HJV5Z)	270 mg  in 15 mL
SODIUM CITRATE (UNII: 1Q73Q2JULR)	45 mg  in 15 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X)	9.37 mg  in 15 mL
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)	0.036 mg  in 15 mL
VANILLA (UNII: Q74T35078H)	0.0006 mL  in 15 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	30 mg  in 15 mL
METHYLPARABEN (UNII: A2I8C7HI9T)	15 mg  in 15 mL
PEPPERMINT (UNII: V95R5KMY2B)	0.001 mL  in 15 mL
PROPYLPARABEN (UNII: Z8IX2SC1OH)	2.25 mg  in 15 mL
WATER (UNII: 059QF0KO0R)	15 mL  in 15 mL

Product Characteristics
Color		Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65131-180-98	1 in 1 BOX	05/01/2017
1		120 mL in 1 BOTTLE, PLASTIC; 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	05/01/2017

Labeler - LABORATORIO MAGNACHEM INTERNATIONAL SRL (871446100)

Registrant - LABORATORIO MAGNACHEM INTERNATIONAL SRL (871446100)

Establishment
Name	Address	ID/FEI	Business Operations
LABORATORIO MAGNACHEM INTERNATIONAL SRL		871446100	manufacture(65131-180)