Label: CODEINE-GUAIFENESIN- codeine phosphate and guaifenesin solution

  • NDC Code(s): 58657-500-04, 58657-500-16
  • Packager: Method Pharmaceuticals, LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 20, 2024

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  • Active ingredient

    (in each teaspoonful (5 mL))
    Codeine Phosphate USP 10 mg

  • Purpose

    Antitussive

  • Active ingredient

    (in each teaspoonful (5 mL))
    Guaifenesin USP 100 mg

  • Purpose

    Expectorant

  • Uses

    • temporarily relieves:
    • cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants
    • your cough to help you sleep
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes cough more productive.
  • Warnings

    Ask your doctor before use if

    • you have a persistent cough, this may be a sign of a serious condition
    • you have a persistent cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
    • you have a cough that is accompanied by excessive phlegm (mucus)
    • you have chronic pulmonary disease or shortness of breath
    • giving to a child who is taking other drugs

    When using this product

    • giving a higher dose than recommended by a doctor could result in serious side effects for your child. A special measuring device should be used to give an accurate dose of this product to children under 6 years of age.
    • may cause or aggravate constipation

    Stop use and ask a doctor if

    • symptoms do not improve within 7 days, tend to recur or are accompanied by fever and rash or persistent headache. These may be symptoms of a serious condition.

    If pregnant or breast-feeding

    ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • do not exceed 6 doses in 24 hours.
    Adults and children
    12 years of age and over:      		2 tsp (10 mL) every 4 hours, or as directed by a doctor. 
    Children 6 to under
    12 years of age:     		1 tsp (5 mL) every 4 hours, or as directed by a doctor.
    Children under
    6 years of age:     		Consult a doctor.
  • Other information

    Store at controlled room temperature 15°-30°C (59°-86°F).

  • Inactive ingredients

    Cherry Flavor, Citric Acid, Glycerin,Masking flavor, Propylene glycol, Purified Water, Sodium Citrate, Sodium Benzoate, Sucralose Sorbitol.

  • Principal Display Panel

    NDC 58657-500-16



    Codeine-Guaifenesin Oral Solution



    10-100 mg/5 mL



    Antitussive



    Expectorant



    16 fl. oz. (473 mL)

    label

  • INGREDIENTS AND APPEARANCE
    CODEINE-GUAIFENESIN 
    codeine phosphate and guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58657-500
    Route of AdministrationORALDEA ScheduleCV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE10 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58657-500-04120 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2014
    2NDC:58657-500-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01204/01/2014
    Labeler - Method Pharmaceuticals, LLC (060216698)
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