BRONCOCHEM KIDS ALLERGY CONTROL- chlorpheniramine maleate-dextromethrophan hbr syrup 
LABORATORIO MAGANCEHM INTERNATIONAL SRL

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.

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BRONCOCHEM KIDS ALLERGY CONTROL

Warnings

Do not use

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

active ingredients

Dextromethorphan HBr.......10.00mg

Chlorpheniramine maleate...2.00mg

Uses

Temporarily relieves cold symptoms, cough, helps loosen phlegm (mucus) and dilute bronchial secretions to make coughs more productive.

Reduces allergic symptoms like runny nose and sneezing, irritated ans watery eyes, Itchy nose, Itchy throat, Allergy rhinitis

Ask a doctor before use if your kid have

Cough with lots of phlegm

Chornic cough, asthma or emphysema

Respiratory problems

Chornic bronchitis

If your child is allergyc to another component of this formula

Stop use and ask a doctor if

Symptoms last more than 5 days

If your child feels dizziness, nervous or cannot sleep

If the cough present fever and headache, this could be signs of a serious conditions

If new symptoms occur

Keep out of the reach of children

Keep out of the reach of children

Overdose warning

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

Directions

Take only as directed, for your convenience a dosage spoon is provided

Do not exceed 4 doses in a 24-hour period

Children from 6 to 12 years-----10mL or cc every 6 hours

Children fron 2 to 6 years-------5mL or cc every 6 hours

Children under 2 years, ask your doctor

Other information

Store at 66-77*F (20-25*C), do not use if security cap is altered or broken

Inactive Ingredients

Propylene glycol, Gliceryn, Sorbitol 70%, Sucralose, Povidone, Sodium Chloride, Aloe vera, Methylparaben USP, Propylparaben USP, Ascorbic acid, Color Yellow #5, Dosodium Hedta, Orange flavor, Sodium hydroxide, Purified water

Quiestions?

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

Purpose

Dextromethorphan HBr------Antitussive

Chlorpheniramine maleate--Antihistamine

Package Label Principal Display Panel

BRONCOCHEM KIDS ALLERGY CONTROL BOX.jpg

Package Label Principal display Panel

Etiq.Broncochem Ninos Allery Control_Bottle Label.jpg

BRONCOCHEM  KIDS ALLERGY CONTROL
chlorpheniramine maleate-dextromethrophan hbr syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65131-418
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg  in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 1.5 mL  in 10 mL
GLYCERIN (UNII: PDC6A3C0OX) 2 mL  in 10 mL
SORBITOL (UNII: 506T60A25R) 2 mL  in 10 mL
SUCRALOSE (UNII: 96K6UQ3ZD4) 8.33 mg  in 10 mL
POVIDONE K90 (UNII: RDH86HJV5Z) 100 mg  in 10 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 6.25 mg  in 10 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) 4 mg  in 10 mL
METHYLPARABEN (UNII: A2I8C7HI9T) 10 mg  in 10 mL
PROPYLPARABEN (UNII: Z8IX2SC1OH) 1.5 mg  in 10 mL
ASCORBIC ACID (UNII: PQ6CK8PD0R) 66 mg  in 10 mL
FD&C YELLOW NO. 5 (UNII: I753WB2F1M) 0.5 mg  in 10 mL
DISODIUM HEDTA (UNII: KME849MC7A) 0.9 mg  in 10 mL
ORANGE (UNII: 5EVU04N5QU) 0.0016 mg  in 10 mL
SODIUM HYDROXIDE (UNII: 55X04QC32I) 13.33 mg  in 10 mL
WATER (UNII: 059QF0KO0R) 10 mL  in 10 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65131-418-091 in 1 BOX05/01/2017
1120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/01/2017
Labeler - LABORATORIO MAGANCEHM INTERNATIONAL SRL (871446100)
Registrant - LABORATORIO MAGNACHEM INTERNATIONAL SRL (871446100)
Establishment
NameAddressID/FEIBusiness Operations
LABORATORIO MAGNACHEM INTERNATIONAL SRL871446100manufacture(65131-418)

Revised: 4/2017
Document Id: d42910c8-7859-41af-ae13-a7e442b6924f
Set id: 36574266-a6ca-443d-9e1d-85240aabe8a2
Version: 1
Effective Time: 20170410
 
LABORATORIO MAGANCEHM INTERNATIONAL SRL