Label: GUAIFENESIN DAC- guaifenesin, codeine phosphate and pseudoephedrine hydrochloride liquid
- NDC Code(s): 16571-301-16
- Packager: Pack Pharmaceuticals LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: CV
- Marketing Status: unapproved drug other
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 1.9%, artificial cherry flavor, caramel, citric acid, disodium edetate, FD&C Red #40, glycerin, menthol, purified water, saccharin sodium, sodium benzoate, sorbitol solution.Close
Temporarily relieves cough and nasal congestion as may occur with a cold. 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 4 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.Close
Do not exceed recommended dosage.
Do not take this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by 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. 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. If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor. If symptoms do not improve within 7 days or are accompanied by fever, consult 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
Do not use this product if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you are uncertain whether your prescription drug contains a MAOI, consult a health professional before taking this product.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.Close
Do not use this product if inner foil seal over the mouth of the bottle is cut, torn, broken or missing.Close
- SPL UNCLASSIFIED SECTION
BULK CONTAINER - NOT FOR HOUSEHOLD USE.
- PRINCIPAL DISPLAY PANEL - 473 mL Bottle
DO NOT REFRIGERATE
Each teaspoon (5 mL) Contains:
Guaifenesin USP 100 mg
Pseudoephedrine Hydrochloride USP 30 mg
Codeine Phosphate USP 10 mg
contains 1.9% alcohol v/v
*Under Federal law Guaifenesin DAC
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, codeine phosphate and pseudoephedrine hydrochloride liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:16571-301 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 Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (Pseudoephedrine - UNII:7CUC9DDI9F) Pseudoephedrine 30 mg in 5 mL Inactive Ingredients Ingredient Name Strength Alcohol (UNII: 3K9958V90M) 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) Menthol (UNII: L7T10EIP3A) Product Characteristics Color RED Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:16571-301-16 473 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved other 09/28/2009 Labeler - Pack Pharmaceuticals LLC (614823875)