Label: BRONCOCHEM KIDS ALLERGY CONTROL- chlorpheniramine maleate-dextromethrophan hbr syrup

  • NDC Code(s): 65131-418-09
  • Packager: LABORATORIO MAGANCEHM INTERNATIONAL SRL
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated April 10, 2017

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  • 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

  • PRINCIPAL DISPLAY PANEL

  • INGREDIENTS AND APPEARANCE
    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)
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