Label: CODEINE-GUAIFENESIN- codeine phosphate and guaifenesin solution

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 22, 2022

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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 Anhydrous, Glycerin, Masking Agent, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate, Sorbitol Solution, Sucralose.

    DISTRIBUTED BY:

    ATLANTIC BIOLOGICALS CORP.

    MIAMI, FL 33179

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

    NDC 17856-0273-01

    CODEINE-GUAIFENESIN 10-100MG - 5 ML CUP 72 ct UD

    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)

    image description

  • INGREDIENTS AND APPEARANCE
    CODEINE-GUAIFENESIN 
    codeine phosphate and guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-0273(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:17856-0273-172 in 1 BOX, UNIT-DOSE11/22/2022
    1NDC:17856-0273-25 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34107/15/2020
    Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
    Establishment
    NameAddressID/FEIBusiness Operations
    UNIT DOSE SOLUTIONS360804194repack(17856-0273)
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