MAR-COF CG EXPECTORANT (CODEINE PHOSPHATE AND GUAIFENESIN) SYRUP [MARNEL PHARMACEUTICALS, LLC]

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MAR-COF CG EXPECTORANT (CODEINE PHOSPHATE AND GUAIFENESIN) SYRUP [MARNEL PHARMACEUTICALS, LLC]
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NDC 0682-0475-16
Set ID 60a41229-b125-43d8-b2b4-0bf40feed764
Category HUMAN OTC DRUG LABEL
Packager Marnel Pharmaceuticals, LLC
Generic Name
Product Class
Product Number
Application Number PART341
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each teaspoonful (5 mL))Purpose
    Codeine Phosphate 7.5 mgAntitussive
    Guaifenesin 225 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 makes cough 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 over1 ½ tsp (7.5 mL) every 4-6 hours
    Children 6 to under 12 years of age¾ tsp (3.75 mL) every 4-6 hours
    Children under 6 years of ageConsult a doctor
  • Other information

    Each teaspoonful contains 6 mg of sodium. Store at controlled room temperature 15°-30°C (59°-86°F).

  • Inactive ingredients

    Citric Acid, Flavors, Glycerin, Polyethylene Glycol, Povidone, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate, Sodium Saccharin, and Sorbitol

  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    MARNEL

    NDC 0682-0475-16

    MAR-COF ®CG
    EXPECTORANT

    ANTITUSSIVE
    (cough suppressant)
    EXPECTORANT

    Each 5mL (one teaspoonful) for oral
    administration contains:

    Codeine Phosphate 7.5 mg
    Guaifenesin 225 mg

    Alcohol-Free / Sugar-Free

    TAMPER EVIDENT:
    Do not use if imprinted safety seal
    under cap is broken or missing.

    16 fl. oz. (473 mL)

    Principal Display Panel - 473 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    MAR-COF CG   EXPECTORANT
    codeine phosphate and guaifenesin syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0682-0475
    Route of AdministrationORALDEA ScheduleCV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE7.5 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN225 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCOTTON CANDYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0682-0475-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/01/2008
    Labeler - Marnel Pharmaceuticals, LLC (080161449)
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