Label: CODEINE-GUAIFENESIN- codeine phosphate and guaifenesin solution

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 1, 2024

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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 mg

    Expectorant
  • Uses

    •
    temporarily relieves:
    o
    cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants
    o
    your cough to help you sleep
    o
    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 Anhydrous, Glycerin, Masking Agent, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate, Sorbitol Solution, Sucralose.

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

    NDC 71205-624-04

    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)

    4 fl. oz. (118 mL)

    71205-624-04
  • INGREDIENTS AND APPEARANCE
    CODEINE-GUAIFENESIN 
    codeine phosphate and guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-624(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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71205-624-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product12/03/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/15/2020
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022RELABEL(71205-624)
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