Label: GUAIFENESIN AND CODEINE PHOSPHATE- guaifenesin and codeine phosphate solution
- NDC Code(s): 0121-0775-04, 0121-0775-16, 0121-1775-05, 0121-1775-10
- Packager: Pharmaceutical Associates, Inc.
- 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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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.Close
This product combines the expectorant, guaifenesin, with the cough suppressant, codeine. Guaifenesin enhances the output of lower respiratory tract fluid. The enhanced flow of less viscid secretions promotes and facilitates the removal of mucus. Codeine is a centrally acting agent which elevates the threshold for cough.
As a result, dry, unproductive coughs become more productive and less frequent.Close
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.Close
Hypersensitivity to any of the ingredients.Close
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).Close
- DRUG INTERACTION PRECAUTION
- DOSAGE and ADMINISTRATION
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.Close
Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). [See USP] Protect from light.Close
- HOW SUPPLIED
Guaifenesin and Codeine Phosphate Oral Solution USP (red color-cherry flavor) is supplied in the following oral dosage forms: NDC 0121-0775-04 (4 fl oz bottle), NDC 0121-0775-16 (16 fl oz bottle), NDC 0121-1775-05 (unit dose cups of 5 mL, 10 × 10's) and NDC 0121-1775-10 (unit dose cups of 10 mL, 10 × 10's).Close
- SPL UNCLASSIFIED SECTION
Greenville, SC 29605
- PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
Guaifenesin and Codeine
Phosphate Oral Solution USP
100 mg/10 mg per 5 mL
Expectorant / Cough Suppressant
Alcohol Free / Sugar Free
Each teaspoonful (5 mL) contains:
Guaifenesin, USP 100 mg
Codeine Phosphate, USP 10 mg
Dispense in a tight, light-resistant
container with a child-resistant closure.
DO NOT ACCEPT IF IMPRINTED SEAL
AROUND CAP IS BROKEN OR MISSING.
16 fl oz (473 mL)
Greenville, SC 29605
- INGREDIENTS AND APPEARANCE
GUAIFENESIN AND CODEINE PHOSPHATE
guaifenesin and codeine phosphate solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0121-0775 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 Phosphate 10 mg in 5 mL 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:0121-0775-04 118 mL in 1 BOTTLE 2 NDC:0121-0775-16 473 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 10/01/2006 GUAIFENESIN AND CODEINE PHOSPHATE
guaifenesin and codeine phosphate solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0121-1775 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 Phosphate 10 mg in 5 mL 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:0121-1775-05 10 in 1 CASE 1 10 in 1 TRAY 1 5 mL in 1 CUP, UNIT-DOSE 2 NDC:0121-1775-10 10 in 1 CASE 2 10 in 1 TRAY 2 10 mL in 1 CUP, UNIT-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 10/01/2006 Labeler - Pharmaceutical Associates, Inc. (044940096) Establishment Name Address ID/FEI Business Operations Pharmaceutical Associates, Inc. 044940096 MANUFACTURE