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 October 3, 2013

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Each 5 mL (1 teaspoonful) contains Guaifenesin, USP 100 mg and Codeine Phosphate, USP 10 mg.

  • ABOUT

    ACTIONS

    This product combines the expectorant, guaifenesin, with the cough suppressant, codeine. Guaifenesin enhances the output of lower respiratory tract fluid. The enhanced flow of less viscid secretions promotes and facilitates the removal of mucus. Codeine is a centrally acting agent which elevates the threshold for cough.

    As a result, dry, unproductive coughs become more productive and less frequent.

    INDICATIONS

    Temporarily controls cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants. Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

    CONTRAINDICATIONS

    Hypersensitivity to any of the ingredients.

  • KEEP OUT OF REACH OF CHILDREN

    In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

  • INDICATIONS & USAGE

    INDICATIONS

    Temporarily controls cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants. Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

    CONTRAINDICATIONS

    Hypersensitivity to any of the ingredients.

  • WARNINGS

    A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache, consult a physician. Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a physician. Adults and children who have a chronic pulmonary disease or shortness of breath, or children who are taking other drugs, should not take this product unless directed by a physician. May cause or aggravate constipation. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

    KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

    Professional Note: Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

    DRUG INTERACTION PRECAUTION

    Caution should be used when taking this product with sedatives, tranquilizers and drugs used for depression, especially monoamine oxidase inhibitors (MAOIs). These combinations may cause greater sedation (drowsiness) than is caused by the products used alone. (See WARNINGS)

  • DOSAGE & HOW SUPPLIED

    Take orally as stated below or use as directed by a physician.

    Adults and children 12 years of age and over:10 mL (2 teaspoonfuls) every 4 hours, not to exceed 12 teaspoonfuls in a 24-hour period; Children 6 to under 12 years:5 mL (1 teaspoonful) every 4 hours, not to exceed 6 teaspoonfuls in a 24-hour period;

    Children under 6 years: Consult a physician. A special measuring device should be used to give an accurate dose of this product to children under 6 years of age.

    Giving a higher dose than recommended by a physician could result in serious side effects for a child.

    Use of codeine-containing preparations is not recommended for children under 2 years of age. Do not exceed recommended dosage.

    STORAGE

    Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F).  Protect from light.

    HOW SUPPLIED

    Guaifenesin and Codeine Phosphate Oral Solution USP (red color-cherry flavor) is supplied in the following oral dosage forms:

     NDC 12634-969-04 (4 fl oz  (120mL) bottle

    Manufactured by:

    Pharmaceutical Associates, Inc.
    Greenville, SC 29605

    Distrubited by:

    Apotheca, Inc.

    Phoenix, AZ 85006

  • INACTIVE INGREDIENT

    Citric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, and sorbitol.

  • PRINCIPAL DISPLAY PANEL

    Guaifenesin & Codeine Phosphate

    Oral Solution USP

    CV

    Expectorant/Cough Suppressant

    Alcohol Free / Sugar Free

    120mL

    NDC 12634-969-04

    guif with codeine

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN AND CODEINE PHOSPHATE 
    guaifenesin and codeine phosphate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12634-969(NDC:0121-1775)
    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
    MENTHOL (UNII: L7T10EIP3A)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12634-969-04120 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/28/2011
    Labeler - Apotheca, Inc (051457844)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca, Inc051457844relabel(12634-969)