GOYESCAS BRONCOVAC 3 COUGH AND COLD (DEXTROMETHORPHAN, GUAIFENESIN, PHENYLEPHRINE) LIQUID [GOYESCAS OF FLA]

GOYESCAS BRONCOVAC 3 COUGH AND COLD (DEXTROMETHORPHAN, GUAIFENESIN, PHENYLEPHRINE) LIQUID [GOYESCAS OF FLA]
PDF | XML

NDC 11856-0025-1
Set ID 227d52d3-7000-05b6-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager GOYESCAS OF FLA
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • Active Ingredients

    Drug Facts

    Active Ingredients: Purpose

    (in each 5 ml. tsp)

    Dextromethorphan HBr USP 10mg Cough Suppresant

    Guaifenesin USP 100mg Expectorant

    Phenylephrine HCI USP 5mg Nasal Decongestant

  • Directions & Dosage

    Directions:

    Dose as follows or as directed by a doctor. For adults and children 12 years of age and older, 1 tablespoonful every 6 hours. For children 6 to under 12 years of age, 1 teaspoonful every 6 hours. For children under 6 years of age, consult a Physician.

  • Warnings

    Warnings:

    Do not use if you are now taking certain drugs for depression, psychiatric or emotional conditions or Parkinson’s disease (MAOI) or for two (2) weeks after stopping (MAOI) drugs. Stop and ask a doctor if cough lasts more than 7 days, if cough comes back or occurs with fever, rash or headache that lasts. Ask a doctor if you are pregnant or breast-feeding. Keep out of reach children. In case of overdose get medical help or contact a Poison Control Center Immediately.

  • Inactive Ingredients

    Inactive ingredients:

    Bee Honey, Echinacea F.E, Flavor, Ginger Root F.E, Glycerin, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, and sucralose.

  • Use

    USE:

    Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes. Temporarily relieves these symptoms occurring with a cold, nasal congestion, cough due to minor throat and bronchial irritation.

  • Purpose

    Active Ingredients: Purpose

    (in each 5 ml. tsp)

    Dextromethorphan HBr USP 10mg Cough Suppresant

    Guaifenesin USP 100mg Expectorant

    Phenylephrine HCI USP 5mg Nasal Decongestant

  • Warnings

    Warnings:

    Do not use if you are now taking certain drugs for depression, psychiatric or emotional conditions or Parkinson’s disease (MAOI) or for two (2) weeks after stopping (MAOI) drugs. Stop and ask a doctor if cough lasts more than 7 days, if cough comes back or occurs with fever, rash or headache that lasts. Ask a doctor if you are pregnant or breast-feeding. Keep out of reach children. In case of overdose get medical help or contact a Poison Control Center Immediately.

  • PRINCIPAL DISPLAY PANEL

    Drug Facts

    Active Ingredients: Purpose

    (in each 5 ml. tsp)

    Dextromethorphan HBr USP 10mg Cough Suppresant

    Guaifenesin USP 100mg Expectorant

    Phenylephrine HCI USP 5mg Nasal Decongestant

    USE:

    Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes. Temporarily relieves these symptoms occurring with a cold, nasal congestion, cough due to minor throat and bronchial irritation.

    Warnings:

    Do not use if you are now taking certain drugs for depression, psychiatric or emotional conditions or Parkinson’s disease (MAOI) or for two (2) weeks after stopping (MAOI) drugs. Stop and ask a doctor if cough lasts more than 7 days, if cough comes back or occurs with fever, rash or headache that lasts. Ask a doctor if you are pregnant or breast-feeding. Keep out of reach children. In case of overdose get medical help or contact a Poison Control Center Immediately.

    Directions:

    Dose as follows or as directed by a doctor. For adults and children 12 years of age and older, 1 tablespoonful every 6 hours. For children 6 to under 12 years of age, 1 teaspoonful every 6 hours. For children under 6 years of age, consult a Physician.

    Inactive ingredients:

    Bee Honey, Echinacea F.E, Flavor, Ginger Root F.E, Glycerin, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, and sucralose.

    Carton

    Label

  • INGREDIENTS AND APPEARANCE
    GOYESCAS BRONCOVAC 3  COUGH AND COLD
    dextromethorphan, guaifenesin, phenylephrine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11856-0025
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX)  
    HONEY (UNII: Y9H1V576FH)  
    GINGER (UNII: C5529G5JPQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11856-0025-11 in 1 BOX
    1177 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/01/2006
    Labeler - GOYESCAS OF FLA (032506248)

Related Drugs