Label: BRONCOCHEM ALLERGY CONTROL- cholpheniramine maleate-phenylephrine hcl syrup

  • NDC Code(s): 65131-098-47
  • Packager: LABORATORIO MAGNACHEM 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 March 14, 2017

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  • Warnings

    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 oharmacist before taking this product.

  • Uses

    Nasal congestion, irritation of the upper respiratory passages, temporarily reduces allergy, swelling of nasal passages, sneezing, itching of the nose or throat, itchy watery eyes, allergic rhinitis.

  • PURPOSE

  • Active ingredients (in 10 mL or cc)

    Chlorpheniramine Maleate.......4.00mg (antihistamine)

    Phenylephrine HCl..................5.00mg (Decongestant)

  • Ask a doctor or Pharmacist if you

    Are taking sedatives or tranquilizers

  • When Using this Product

    Excitability may occur, especially in children.

    May cause marked drowsiness

    Avoid alcoholic drinks

    Alcohol, sedatives and tranquilizers may increase drowsiness

    Be careful when driving or operating machinery

  • Stop Use and Ask a Doctor If

    Nervousness, dizziness or sleeplessness occur.

    Symptoms last more than five days.

    If fever is presented that last more than 3 days or headache appers, this could be signs of a serious condition.

  • Keep Out of the Reach of children

    Keep out of the reach of children.

    If pregnant or breast-feeding, ask a doctor before taking this product.

  • Overdose warning

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

  • Directions

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

    Adults and Children from 12 years above 10mL or cc every 6 hours.

    Children from 6 to 12 years 5mL or cc every 6 hours.

    Children under 6 years, ask your doctor.

  • Other Information

    Store at 66-77

  • Inactive Ingredients

    Propylene glycol, Glicerin, Sorbitol 70% USP, sucralose, Povidone, Sodium chloride, Aloe Vera, Metil paraben USP, Propil paraben USP, Propyl gallate, Citric acid, Sodium citrate dihydrate, EDTA disodium, Grape flavor, Purified water.

  • Questions

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

    Made in Dominican Republic by Laboratorio Magnachem International SRL to Global Corporation Inc. Boca Raton, Fl 33487

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    CAJA_BRONCOCHEM ALLERGY 120mL.jpg

  • PAKAGE LABEL.PRINCIPAL DISPLAY PANEL

    ETIQ.BRONCOCHEM ALLERGY CONTROL.jpg

  • PRINCIPAL DISPLAY PANEL

  • INGREDIENTS AND APPEARANCE
    BRONCOCHEM  ALLERGY CONTROL
    cholpheniramine maleate-phenylephrine hcl syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65131-098
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg  in 10 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE10 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 1.2 mL  in 10 mL
    GLYCERIN (UNII: PDC6A3C0OX) 2 mL  in 10 mL
    SORBITOL (UNII: 506T60A25R) 2 mL  in 10 mL
    SUCRALOSE (UNII: 96K6UQ3ZD4) 7.5 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
    PROPYL GALLATE (UNII: 8D4SNN7V92) 1 mg  in 10 mL
    CITRIC ACID ACETATE (UNII: DSO12WL7AU) 20 mg  in 10 mL
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) 40 mg  in 10 mL
    EDETATE SODIUM (UNII: MP1J8420LU) 0.9 mg  in 10 mL
    GRAPEFRUIT (UNII: O82C39RR8C) 0.0048 mL  in 10 mL
    WATER (UNII: 059QF0KO0R) 10 mL  in 10 mL
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorgrapeImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65131-098-471 in 1 BOX04/01/2017
    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 finalpart34104/01/2017
    Labeler - LABORATORIO MAGNACHEM INTERNATIONAL SRL (871446100)
    Registrant - LABORATORIO MAGNACHEM INTERNATIONAL SRL (871446100)
    Establishment
    NameAddressID/FEIBusiness Operations
    LABORATORIO MAGNACHEM INTERNATIONAL SRL871446100manufacture(65131-098)
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