Label: CODEINE GUAIFENESIN- codeine phosphate, guaifenesin solution

  • NDC Code(s): 69315-248-12, 69315-248-48
  • Packager: Leading Pharma, LLC
  • 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 January 10, 2020

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  • Drug Facts

    Active Ingredients                                                              Purpose

    (in each teaspoonful (5 mL))

    Codeine Phosphate USP 10 mg ................... Antitussive

    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 makes cough more productive
  • INDICATIONS & USAGE

  • 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.

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

  • 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.

  • INFORMATION FOR PATIENTS

    Other Information

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

  • Inactive ingredients

    Cherry Flavor, Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol

  • QUESTIONS

    Manufactured For:

    Leading Pharma, LLC

    Fairfield, NJ 07004

    Rev. 07/2019

  • PRINCIPAL DISPLAY PANEL

    containerlable120ml

    containerlable473ml

  • INGREDIENTS AND APPEARANCE
    CODEINE GUAIFENESIN 
    codeine phosphate, guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69315-248
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69315-248-48473 mL in 1 BOTTLE; Type 0: Not a Combination Product12/19/2019
    2NDC:69315-248-12120 mL in 1 BOTTLE; Type 0: Not a Combination Product12/19/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/19/2019
    Labeler - Leading Pharma, LLC (079575060)
    Registrant - Leading Pharma, LLC (079575060)
    Establishment
    NameAddressID/FEIBusiness Operations
    Woodfield Pharmaceuticals, LLC079398730manufacture(69315-248)