GUAIFENESIN AC (GUAIFENESIN AND CODEINE PHOSPHATE) SYRUP [RISING PHARMACEUTICALS]

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GUAIFENESIN AC (GUAIFENESIN AND CODEINE PHOSPHATE) SYRUP [RISING PHARMACEUTICALS]
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NDC 16571-302-16
Set ID e4a455ae-07bd-43aa-b607-7179dcda7ded
Category HUMAN OTC DRUG LABEL
Packager Rising Pharmaceuticals
Generic Name
Product Class
Product Number
Application Number PART341
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  • ACTIVE INGREDIENT

    Each teaspoon (5 mL) Contains:
    Guaifenesin USP100 mg
    Codeine Phosphate USP10 mg

    contains 3.5% alcohol v/v

  • INACTIVE INGREDIENTS

    Alcohol 3.5%, artificial cherry flavor, caramel, citric acid, disodium edetate, FD&C Red #40, glycerin, purified water, saccharin sodium, sodium benzoate, sorbitol solution.

  • INDICATIONS

    Temporarily relieves 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.

  • DIRECTIONS

    Take every 4 hours or as directed by a doctor. Do not exceed 6 doses in 24 hours. Adults and children 12 years of age and over: Take 2 teaspoons. Children 6 to under 12 years of age: Give 1 teaspoon. Children under 6 years of age: DO NOT USE. Giving a higher dose than recommended by a doctor could result in serious side effects for your child.

  • WARNINGS

    Do not exceed recommended dosage. Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. 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 doctor. 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 doctor. 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. Do not use in children following a tonsillectomy and/or adenoidectomy as this could cause severe respiratory distress.

  • 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 product used alone.

    TO REPORT ADVERSE DRUG EVENTS CALL: (866) 562-4597

  • STORAGE AND HANDLING

    Dispense in a tight, light-resistant container as defined in the USP.

    Store at controlled room temperature 20o - 25o C (68o - 77oF). (see USP Controlled Room Temperature) DO NOT REFRIGERATE.

  • OTHER INFORMATION

    Each 5 mL contains: sodium 4 mg

  • TAMPER-EVIDENT

    Do not use this product if inner foil seal over the mouth of the bottle is cut, torn, broken or missing.

  • SPL UNCLASSIFIED SECTION

    BULK CONTAINER - NOT FOR HOUSEHOLD USE.

    REV 2/15

  • SPL UNCLASSIFIED SECTION

    Manufactured by:
    Bio-Pharm, Incorporated Levittown, PA 19057

    Distributed by:
    Rising Pharmaceuticals, Inc. Allendale, NJ 07401

  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    Rising® NDC 16571-302-16

    Guaifenesin AC
    Cough Syrup

    CV

    SUGAR-FREE

    GUAIFENESIN AND CODEINE
    PHOSPHATE ORAL SOLUTION, USP)
    COUGH SUPPRESSANT
    EXPECTORANT

    Each teaspoon (5 mL) Contains:Guaifenesin USP....... 100 mg
    Codeine Phosphate USP..... 10 mg

    contains 3.5% alcohol v/v

    *Under Federal law Guaifenesin AC is available
    without a prescription. Certain State laws may differ.

    Manufactured by:
    Bio-Pharm, Incorporated Levittown, PA 19057

    Distributed by:
    Rising Pharmaceuticals, Inc. Allendale, NJ 07401

    TAMPER-EVIDENT
    DO NOT REFRIGERATE

    ONE PINT (473 mL)

    LABEL

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN AC 
    guaifenesin and codeine phosphate syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16571-302
    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
    Alcohol (UNII: 3K9958V90M)  
    Cherry (UNII: BUC5I9595W)  
    Caramel (UNII: T9D99G2B1R)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    FD&C Red no. 40 (UNII: WZB9127XOA)  
    Glycerin (UNII: PDC6A3C0OX)  
    Water (UNII: 059QF0KO0R)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Sorbitol (UNII: 506T60A25R)  
    Product Characteristics
    ColorBROWNScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16571-302-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER03/01/2015
    Labeler - Rising Pharmaceuticals (835513529)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bio-Pharm, Inc.801652546MANUFACTURE(16571-302) , ANALYSIS(16571-302) , PACK(16571-302) , LABEL(16571-302)
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