Label: GUAIFENESIN AC- guaifenesin and codeine phosphate syrup
- NDC Code(s): 16571-302-16
- Packager: Pack Pharmaceuticals LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: CV
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- 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.Close
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.Close
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.Close
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.
- 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.Close
- STORAGE AND HANDLING
Dispense in a tight, light-resistant container as defined in the USP.
Store at controlled room temperature 20°-25° C (68 °-77°F). (see USP Controlled Room Temperature) DO NOT REFRIGERATE.Close
- 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.
BULK CONTAINER - NOT FOR HOUSEHOLD USE.
TO REPORT ADVERSE DRUG EVENTS CALL: (866) 562-4597Close
- PRINCIPAL DISPLAY PANEL - 473 mL Bottle
DO NOT REFRIGERATE
Guaifenesin AC CV
(GUAIFENESIN AND CODEINE
PHOSPHATE ORAL SOLUTION USP)
COUGH SUPPRESSANT • EXPECTORANT
Each teaspoon (5mL) 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
Distributed by: PACK PHARMACEUTICALS, LLC
Buffalo Grove, IL 60089 REV 08/09
TO REPORT ADVERSE DRUG EVENTS CALL:
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 - UNII:Q830PW7520) Codeine 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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 09/22/2009 Labeler - Pack Pharmaceuticals LLC (614823875)