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

  • NDC Code(s): 65131-109-84
  • Packager: LABORATORIO MAGNACHEM INTERNATIONAL SRL
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 23, 2025

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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..................10.00mg

  • 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 6 doses in a 24 hour period

    Children from 6 to 12 years-----10mL or cc every 4 hours

    Children under 6 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.jpgCAJA BRONCOCHEM KIDS COLD & FLU.jpgCAJA BRONCOCHEM KIDS COLD & FLU.jpg

  • Package Label Principal Display Panel

    Etiq.Broncochem Ninos Cold and Flu Syrup_Bottle Label.jpgEtiq.Broncochem Ninos Cold and Flu Syrup_Bottle Label.jpgEtiq.Broncochem Ninos Cold and Flu Syrup_Bottle Label.jpg

  • INGREDIENTS AND APPEARANCE
    BRONCOCHEM  KIDS COLD AND FLU
    acetaminophen-phenylephrine hcl-guaifenesin syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65131-109
    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 HYDROCHLORIDE10 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:65131-109-841 in 1 BOX04/21/2025
    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 DrugM04/21/2025
    Labeler - LABORATORIO MAGNACHEM INTERNATIONAL SRL (871446100)
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