Label: CODEINE-GUAIFENESIN- codeine phosphate and guaifenesin solution

  • NDC Code(s): 69367-272-04, 69367-272-16
  • Packager: Westminster Pharmaceuticals, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: CV

Drug Label Information

Updated July 16, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 5 mL = 1 tsp)Purpose
    Codeine phosphate, USP 10 mg  Antitussive
    Guaifenesin, USP 100 mgExpectorant
  • 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 make coughs 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 the 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).

    You may report side effects by calling 1-844-221-7294 or FDA at 1-800-FDA-1088.

  • Inactive Ingredients

    Cherry flavor, citric acid, methylparaben, potassium citrate, potassium sorbate, propylparaben, propylene glycol, purified water, sorbitol, sucralose.

  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    NDC 69367-272-16

    Codeine-
    Guaifenesin
    Oral Solution
    10-100 mg/5 mL

    Antitussive/Expectorant

    Sugar Free, Alcohol Free, Dye Free

    Each 5 mL (1 teaspoonful) contains:
    Codeine phosphate, USP
    10 mg
    Guaifenesin, USP
    100 mg

    (WARNING: May be habit-forming)

    Tamper evident by foil seal under cap.
    Do not use if foil seal is broken or missing.

    16 fl. oz. (473 mL)

    Westminster
    Pharmaceuticals

    PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    CODEINE-GUAIFENESIN 
    codeine phosphate and guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69367-272
    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)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69367-272-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product07/15/2020
    2NDC:69367-272-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM01207/15/2020
    Labeler - Westminster Pharmaceuticals, LLC (079516651)
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