Label: GUAIFENESIN AND CODEINE PHOSPHATE solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: CV
  • Marketing Status: OTC monograph final

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 February 16, 2023

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  • Drug Facts

    Active ingredients
    (in each 5 mL = 1 tsp)

                                                                 Purpose

    Codeine phosphate, USP 10 mg

                                                                 Cough suppressant

    Guaifenesin, USP 100 mg

                                                                 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 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.
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    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

    Each tsp (5 mL) contains 3 mg sodium. 
    Store at controlled room temperature 15°-30°C (59°-86°F). You may report side effects by calling 1-888-344-9603 or FDA at 1-800-FDA-1088.

  • Inactive ingredients

    Caramel flavor, cherry flavor, citric acid, glycerin, peppermint flavor, purified water, sodium benzoate, sodium saccharin, sorbitol.

  • SPL UNCLASSIFIED SECTION

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

    Manufactured by:
    Quagen Pharmaceuticals LLC
    West Caldwell, NJ 07006

    MADE IN USA

  • PRINCIPAL DISPLAY PANEL

    pdp

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN AND CODEINE PHOSPHATE 
    guaifenesin and codeine phosphate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68071-2935(NDC:70752-180)
    Route of AdministrationORALDEA ScheduleCV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE10 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCARAMEL, CHERRY, PEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68071-2935-4118 mL in 1 BOTTLE; Type 0: Not a Combination Product02/16/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/23/2022
    Labeler - NuCare Pharmaceuticals,Inc. (010632300)
    Establishment
    NameAddressID/FEIBusiness Operations
    NuCare Pharmaceuticals,Inc.010632300relabel(68071-2935)
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