{"active_ingredient":["Active ingredient (in each TSP (5 mL)) Purposes Codeine Phosphate, USP 10 mg Cough suppressant Guaifenesin USP 100 mg Expectorant"],"active_ingredient_table":["
Active ingredient (in each TSP (5 mL)) Purposes
Codeine Phosphate, USP 10 mg Cough suppressant
Guaifenesin USP 100 mg Expectorant
"],"ask_doctor":["Ask a doctor before use if you have a cough with too much phlegm (mucus) a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking 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."],"do_not_use":["Do not use in adults and children who have a chronic pulmonary disease or shortness of breath, or children who are taking other drugs, unless directed by a doctor. In children following a tonsillectomy and/or adenoidectomy as this could cause severe respiratory distress."],"dosage_and_administration":["Directions take every 4 hours do not exceed 6 doses in 24 hours giving a higher dose than recommended by a doctor can result in serious side effects for a child. Do not exceed recommended dosage. not intended for use in children under 6 years of age TSP = teaspoonful Age Dose adults and children 12 years and over 2 TSP children 6 to under 12 years of age 1 TSP children under 6 years of age do not use"],"dosage_and_administration_table":["
Age Dose
adults and children 12 years and over 2 TSP
children 6 to under 12 years of age 1 TSP
children under 6 years of age do not use
"],"effective_time":"20190925","id":"9363d79b-6c58-57d7-e053-2995a90a1fc7","inactive_ingredient":["Inactive ingredients alcohol 3.5% v/v, artificial cherry flavor, caramel, citric acid, disodium EDTA, FD&C red # 40, glycerin, purified water, saccharin sodium, sodium benzoate, sorbitol solution"],"indications_and_usage":["Uses temporarily relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive"],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Use of codeine-containing preparation is not recommended for children under 2 years of age"],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label NDC 0904-6479-16 Robafen AC ™ Oral Solution CV (GUAIFENESIN AND CODEINE PHOSPHATE ORAL SOLUTION USP) ANTITUSSIVE • EXPECTORANT SUGAR FREE Under Federal law Robafen AC is available without a prescription. Certain State laws may differ. BULK CONTAINER - NOT FOR HOUSEHOLD USE. TAMPER-EVIDENT DO NOT REFRIGERATE Manufactured by: Bio-Pharm, Inc. Levittown, PA 19057 Distributed by: MAJOR ® PHARMACEUTICALS 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152 35-8045-16 REV 08/17 M-64 ONE PINT (473 mL) MAJOR ® PHARMACEUTICALS PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Active ingredient (in each TSP (5 mL)) Purposes Codeine Phosphate, USP 10 mg Cough suppressant Guaifenesin USP 100 mg Expectorant"],"purpose_table":["
Active ingredient (in each TSP (5 mL)) Purposes
Codeine Phosphate, USP 10 mg Cough suppressant
Guaifenesin USP 100 mg Expectorant
"],"questions":["Questions or comments? 1-800-616-2471"],"set_id":"e910cc7a-574a-4b3a-b32a-4ba077312873","spl_product_data_elements":["Robafen AC Guaifenesin and Codeine Phosphate ALCOHOL CHERRY CARAMEL ANHYDROUS CITRIC ACID EDETATE DISODIUM FD&C RED NO. 40 GLYCERIN WATER SACCHARIN SODIUM SODIUM BENZOATE SORBITOL GUAIFENESIN GUAIFENESIN CODEINE PHOSPHATE CODEINE ANHYDROUS"],"spl_unclassified_section":["Drug Facts","Manufactured by: Bio-Pharm, Inc. Levittown, PA 19057 Distributed by: MAJOR ® PHARMACEUTICALS 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152"],"stop_use":["Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These can be signs of a serious condition. may cause or aggravate constipation"],"storage_and_handling":["Other information each (5 mL) teaspoon contains : 4 mg sodium Tamper evident: Do not use this product if inner foil seal over the mouth of the bottle is torn, broken or missing. Keep container closed and store away from heat. DO NOT REFRIGERATE. Store at room temperature 20°-25°C (68°-77°F) Dispense in a tight, light-resistant container as defined in the USP."],"version":"3","warnings":["Warnings Do not use in adults and children who have a chronic pulmonary disease or shortness of breath, or children who are taking other drugs, unless directed by a doctor. In children following a tonsillectomy and/or adenoidectomy as this could cause severe respiratory distress. Ask a doctor before use if you have a cough with too much phlegm (mucus) a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema Ask a doctor or pharmacist before use if you are taking 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. Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These can be signs of a serious condition. may cause or aggravate constipation If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Use of codeine-containing preparation is not recommended for children under 2 years of age"]}