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RelCof-C (Burel Pharmaceuticals, LLC)

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LIQUID 473 mL in 1 BOTTLE (35573-006-16) Label Information

Complete RelCof-C Information


    Drug Facts


    Active ingredients
    (in each teaspoonful (5 mL))
    Codeine Phosphate 6.3 mg Antitussive
    Guaifenesin 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.

  • 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 3 tsp (15 mL) every 4 - 6 hours
    Children 6 to under 12 years of age 1 ½ tsp (7.5 mL) every 4 - 6 hours
    Children under 6 years of age Consult 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, Cherry Flavor, Glycerin, Polyethylene Glycol, Povidone, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate, Sodium Saccharin, and Sorbitol.

  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    NDC 35573-006-16


    (cough suppressant)

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

    Codeine Phosphate 6.3 mg
    Guaifenesin 100 mg

    Do not use if imprinted
    neck band is broken or missing.


    Mfg. for: Burel Pharmaceuticals, Inc.
    464 Church Road Ste. 100
    Madison, MS 39110

    16 fl. oz. (473 mL)

    Principal Display Panel - 473 mL Bottle Label

    codeine phosphate and guaifenesin liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:35573-006
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Codeine Phosphate (UNII: GSL05Y1MN6) (Codeine - UNII:Q830PW7520) Codeine Phosphate 6.3 mg  in 5 mL
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin 100 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Glycerin (UNII: PDC6A3C0OX)  
    Polyethylene Glycol (UNII: 3WJQ0SDW1A)  
    Povidone (UNII: FZ989GH94E)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Water (UNII: 059QF0KO0R)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Sodium Citrate (UNII: 1Q73Q2JULR)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Sorbitol (UNII: 506T60A25R)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor CHERRY Imprint Code
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:35573-006-16 473 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 09/02/2009
    Labeler - Burel Pharmaceuticals, LLC (002152814)