Label: GUAIFENESIN AC- guaifenesin and codeine phosphate syrup
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: CV
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Updated December 14, 2017
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENTS
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.
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.
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
- OTHER INFORMATION
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
Rising® NDC 16571-302-16
GUAIFENESIN AND CODEINE
PHOSPHATE ORAL SOLUTION, USP)
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.
Bio-Pharm, Incorporated Levittown, PA 19057
Rising Pharmaceuticals, Inc. Allendale, NJ 07401
DO NOT REFRIGERATE
ONE PINT (473 mL)
INGREDIENTS AND APPEARANCE
guaifenesin and codeine phosphate syrup
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:16571-302 Route of Administration ORAL DEA Schedule CV Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin 100 mg in 5 mL Codeine Phosphate (UNII: GSL05Y1MN6) (Codeine Anhydrous - UNII:UX6OWY2V7J) Codeine Phosphate 10 mg in 5 mL Inactive Ingredients Ingredient Name Strength 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 Color BROWN Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:16571-302-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 03/01/2015 Labeler - Rising Pharmaceuticals (835513529) Establishment Name Address ID/FEI Business Operations Bio-Pharm, Inc. 801652546 MANUFACTURE(16571-302) , ANALYSIS(16571-302) , PACK(16571-302) , LABEL(16571-302)