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BRONCOCHEM MAXIMUM COUGH KIDS

Dosage form: syrup
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 10mg in 15mL, GUAIFENESIN 100mg in 15mL
Labeler: LABORATORIO MAGNACHEM INTERNATIONAL SRL
NDC Code: 65131-180

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.

BRONCOCHEM MAXIMUM COUGH KIDS

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

BRONCOCHEM  MAXIMUM COUGH KIDS
dextromethorphan hbr-guaifenesin syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65131-180
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 15 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL2.25 mL  in 15 mL
GLYCERIN2.25 mL  in 15 mL
SORBITOL2.25 mL  in 15 mL
SUCRALOSE15 mg  in 15 mL
ANHYDROUS CITRIC ACID45 mg  in 15 mL
DISODIUM HEDTA1.35 mg  in 15 mL
POVIDONE K90270 mg  in 15 mL
SODIUM CITRATE45 mg  in 15 mL
SODIUM CHLORIDE9.37 mg  in 15 mL
FD&C GREEN NO. 30.036 mg  in 15 mL
VANILLA0.0006 mL  in 15 mL
ALOE VERA LEAF30 mg  in 15 mL
METHYLPARABEN15 mg  in 15 mL
PEPPERMINT0.001 mL  in 15 mL
PROPYLPARABEN2.25 mg  in 15 mL
WATER15 mL  in 15 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:65131-180-981 BOTTLE, PLASTIC in 1 BOX
1120 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/01/2017
Labeler - LABORATORIO MAGNACHEM INTERNATIONAL SRL (871446100)
Registrant - LABORATORIO MAGNACHEM INTERNATIONAL SRL (871446100)
Establishment
NameAddressID/FEIOperations
LABORATORIO MAGNACHEM INTERNATIONAL SRL871446100manufacture(65131-180)

 
LABORATORIO MAGNACHEM INTERNATIONAL SRL

Medically reviewed on Apr 10, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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