GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DIRECTRX]

GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DIRECTRX]
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NDC 61919-110-04
Set ID 91e9e5e2-5178-4476-9333-02c27bfc4f70
Category HUMAN OTC DRUG LABEL
Packager DirectRX
Generic Name
Product Class
Product Number
Application Number PART341
  • DESCRIPTION SECTION

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

      Inactive Ingredients: 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.

      Sodium Content: 5 mg/5 mL

      Under federal law, Guaifenesin and Codeine Phosphate Oral Solution USP is available without a prescription. Certain state laws may differ.

  • CONTRAINDICATIONS SECTION

    Hypersensitivity to any of the ingredients

  • WARNINGS SECTION

    • 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 INTERACTIONS SECTION

    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 & ADMINISTRATION SECTION

    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 AND HANDLING SECTION

    STORAGEKeep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). [See USP] Protect from light.

  • OTC - ACTIVE INGREDIENT SECTION

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

  • OTC - PURPOSE SECTION

    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.

  • OTC - KEEP OUT OF REACH OF CHILDREN SECTION

    KEEP OUT OF REACH OF CHILDREN

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    image description

  • INDICATIONS & USAGE SECTION

    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.

  • INACTIVE INGREDIENT SECTION

    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.

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN AND CODEINE PHOSPHATE 
    guaifenesin and codeine phosphate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61919-110(NDC:0121-0775)
    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
    edetate disodium (UNII: 7FLD91C86K)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    FD&C Red No. 40 (UNII: WZB9127XOA)  
    FD&C Yellow No. 6 (UNII: H77VEI93A8)  
    menthol (UNII: L7T10EIP3A)  
    propylene glycol (UNII: 6DC9Q167V3)  
    sodium benzoate (UNII: OJ245FE5EU)  
    sodium citrate (UNII: 1Q73Q2JULR)  
    sorbitol (UNII: 506T60A25R)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61919-110-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/01/2015
    Labeler - DirectRX (079254320)
    Establishment
    NameAddressID/FEIBusiness Operations
    DirectRX079254320repack(61919-110)

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