Codeine Phosphate and Guaifenesin Codeine Phosphate and Guaifenesin Codeine Phosphate Codeine Anhydrous Guaifenesin Guaifenesin ALCOHOL SACCHARIN SODIUM CITRIC ACID MONOHYDRATE SORBITOL FD&C Red NO. 40 glycerin WATER SODIUM BENZOATE
Drug Facts
Composition & Profile
Identifiers & Packaging
PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label VIRTUS ® PHARMACEUTICALS NDC: 69543- 276 -16 Codeine phosphate and Guaifenesin oral solution 10 mg/100 mg Per 5 mL Antitussive Expectorant CV SUGAR FREE Each 5 mL (1 teaspoonful) contains: Codeine Phosphate, USP 10 mg Guaifenesin, USP 100 mg (WARNING: May be habit-forming) Alcohol 3.8% Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing 16 fl. oz. (473 mL) PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
- PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label VIRTUS ® PHARMACEUTICALS NDC: 69543- 276 -16 Codeine phosphate and Guaifenesin oral solution 10 mg/100 mg Per 5 mL Antitussive Expectorant CV SUGAR FREE Each 5 mL (1 teaspoonful) contains: Codeine Phosphate, USP 10 mg Guaifenesin, USP 100 mg (WARNING: May be habit-forming) Alcohol 3.8% Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing 16 fl. oz. (473 mL) PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
Overview
Uses • temporarily relieves: • cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants • your cough to help you sleep • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough more productive.
Indications & Usage
Uses • temporarily relieves: • cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants • your cough to help you sleep • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough more productive.
Dosage & Administration
Directions • do not exceed 6 doses in 24 hours. Adults and children 12 years of age and over: 2 tsp (10 mL) every 4 hours, or as directed by a doctor. Children 6 to under 12 years of age: 1 tsp (5 mL) every 4 hours, or as directed by a doctor. Children under 6 years of age: Consult a doctor.
Warnings & Precautions
Warnings Ask your doctor before use if • you have a persistent cough, this may be a sign of a serious condition • you have a persistent cough such as occurs with smoking, asthma, chronic bronchitis or emphysema • you have a cough that is accompanied by excessive phlegm (mucus) • you have chronic pulmonary disease or shortness of breath • giving to a child who is taking other drugs When using this product • giving a higher dose than recommended by a doctor could result in serious side effects for your child. A special measuring device should be used to give an accurate dose of this product to children under 6 years of age. • may cause or aggravate constipation Stop use and ask a doctor if • symptoms do not improve within 7 days, tend to recur or are accompanied by fever and rash or persistent headache. These may be symptoms of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Purpose
Active Ingredients (In each 5 mL = 1 tsp) Purpose Codeine Phosphate, USP 10 mg Antitussive Guaifenesin, USP 100 mg Expectorant
When Using
When using this product • giving a higher dose than recommended by a doctor could result in serious side effects for your child. A special measuring device should be used to give an accurate dose of this product to children under 6 years of age. • may cause or aggravate constipation
Stop Use & Ask a Doctor
Stop use and ask a doctor if • symptoms do not improve within 7 days, tend to recur or are accompanied by fever and rash or persistent headache. These may be symptoms of a serious condition.
Keep Out of Reach of Children
Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Storage & Handling
Other information Each tsp (5 mL) contains 4 mg sodium. Store at controlled room temperature 15° to 30°C (59° to 86° F). You may report side effects by calling Virtus Pharmaceuticals, LLC at 1-888-848-3593 or FDA at 1-800-FDA-1088
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