Label: BRONCOCHEM KIDS COLD AND FLU- acetaminophen-phenylephrine hcl-guaifenesin syrup

  • NDC Code(s): 65131-054-18
  • 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 April 6, 2017

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  • Warnings

    Liver warnings: this producto contains acetaminophen; severe liver damage may occur if you take:

    More than 4 doses in 24 hour, wich is the maximum daily amount for this product.

    With other drugs containing acetaminophen.

    Sore throat warnings: if sore throat is severe, persist for more than 2 days, is accompanied or followed by fever, headache, rash, nauseas or vomiting, consult a doctor promptly.

    allergy warnings: acetaminophen may cause severe skin reactions; symptoms may include:

    Sking reddening, blisters, rash.  If sking reactions occurs, stop use and seek medical attention.

  • Uses

    Bronchial congestion, irritation of the respiratory passages, helps loosen phlegm (mucus) and dilute bronchial secretions, temporarily reduces fever and minor pains associated with cold, headache, and sore throat.

  • Active Ingredients

    Acetaminophen...................325.00mg

    Guaifenesin........................200.00mg

    Phenylephrine HCl..................5.00mg

  • Ask a doctor before use if your kid have

    Liver disease

    Persistent or chronic cough, asthma or emphysema

    If your kid is allergic to acetaminophen or any other componet of this formula

  • Stop use and ask a doctor if

    Symtoms last more than 5 days

    Fever gets worst or last more than 3 days, or occurs with rash or headache that last, a persistent cough, this could be signs of a serious conditions

    If your child is taking the bloood thinning drug warfarin

  • 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 inmediately

  • 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 form 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 securety cap is altered or broken

  • Inactive ingredients

    Propylene glycol, glycerin, Sorbitol USP, Sucralose, Citric acid, disodium Hedta, Povidone, Sodium citrate dihydrate, Sodium chloride, Honey, Propyl gallate, FD&C Red #40, Aloe Vera, Methylparaben USP, Propylparaben USP, Bubble Gum flavor, Raspberry flavor, Nat. Masking type #27872, Purified water.

  • Quiestions?

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

  • Purose

    Acetaminophen...........Analgesic

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

    Phenylephrine.............Decongestant

  • Package principal display panel

    CAJA BRONCOCHEM KIDS COLD & FLU.jpg

  • Package Label Principal Display Panel

    Etiq.Broncochem Ninos Cold and Flu Syrup_Bottle Label.jpg

  • PRINCIPAL DISPLAY PANEL

  • INGREDIENTS AND APPEARANCE
    BRONCOCHEM  KIDS COLD AND FLU
    acetaminophen-phenylephrine hcl-guaifenesin syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65131-054
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 10 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 10 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 1.5 mL  in 10 mL
    GLYCERIN (UNII: PDC6A3C0OX) 2.5 mL  in 10 mL
    SORBITOL (UNII: 506T60A25R) 2 mL  in 10 mL
    SUCRALOSE (UNII: 96K6UQ3ZD4) 15 mg  in 10 mL
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 20 mg  in 10 mL
    DISODIUM HEDTA (UNII: KME849MC7A) 0.9 mg  in 10 mL
    POVIDONE K90 (UNII: RDH86HJV5Z) 100 mg  in 10 mL
    SODIUM CITRATE (UNII: 1Q73Q2JULR) 40 mg  in 10 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 6.25 mg  in 10 mL
    HONEY (UNII: Y9H1V576FH) 100 mg  in 10 mL
    PROPYL GALLATE (UNII: 8D4SNN7V92) 1 mg  in 10 mL
    FD&C RED NO. 40 (UNII: WZB9127XOA) 0.16 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
    RASPBERRY (UNII: 4N14V5R27W) 0.0048 mL  in 10 mL
    WATER (UNII: 059QF0KO0R) 10 mL  in 10 mL
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65131-054-181 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 MAGNACHEM INTERNATIONAL SRL (871446100)
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