{"active_ingredient":["Active ingredient (in each 2 TSP (10 mL) ) Guaifenesin USP 200 mg"],"ask_doctor":["Ask a doctor before use if you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema a cough occurs with too much phlegm (mucus)"],"dosage_and_administration":["Directions do not take more than 6 doses in any 24 hour period this product is not intended for use in children under 12 years of age TSP = teaspoonful adults and children 12 years and over 2 - 4 TSP every 4 hours children under 12 years do not use"],"dosage_and_administration_table":["<table width=\"70%\" styleCode=\"Noautorules\"> <col width=\"60%\" align=\"left\" valign=\"top\"/> <col width=\"40%\" align=\"left\" valign=\"top\"/> <tbody> <tr styleCode=\"Botrule\"> <td styleCode=\"Toprule Rrule\">adults and children 12 years and over</td> <td styleCode=\"Toprule\">2 - 4 TSP every 4 hours</td> </tr> <tr> <td styleCode=\"Rrule\">children under 12 years</td> <td>do not use</td> </tr> </tbody> </table>"],"effective_time":"20190930","id":"93c5eb05-cf18-4dda-e053-2a95a90a874f","inactive_ingredient":["Inactive ingredients caramel powder, citric acid, corn syrup, FD&C Red #40, glycerin, menthol, propylene glycol, purified water, saccharin sodium, sodium benzoate"],"indications_and_usage":["Uses helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive"],"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."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label NDC 0904-0061-16 TAMPER-EVIDENT Robafen™ Syrup (brand of Guaifenesin syrup USP 100 mg per 5 mL) EXPECTORANT Each 2 teaspoonful (10 mL) contains: Guaifenesin (Glyceryl Guaiacolate), USP 200 mg TAMPER-EVIDENT: Do not use this product if inner foil seal over the mouth of the bottle is cut, torn, broken or missing. For Dispensing Purpose Only Distributed by MAJOR ® PHARMACEUTICALS 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152 NET: 1 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":["Purpose Expectorant"],"questions":["Questions or comments? (800) 616-2471"],"set_id":"272a2819-9713-4e33-a14e-8be6f8bfebf8","spl_product_data_elements":["ROBAFEN COUGH FORMULA Guaifenesin PROPYLENE GLYCOL SODIUM BENZOATE SACCHARIN SODIUM ANHYDROUS CITRIC ACID GLYCERIN MENTHOL, UNSPECIFIED FORM CORN SYRUP WATER CARAMEL FD&C RED NO. 40 GUAIFENESIN GUAIFENESIN Reddish-Brown"],"spl_unclassified_section":["Drug Facts","Distributed by MAJOR ® PHARMACEUTICALS 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152"],"stop_use":["Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition."],"storage_and_handling":["Other information each TSP (5 mL) contains: sodium 3 mg store at 20°-25°C (68°-77°F). Do not refrigerate."],"version":"5","warnings":["Warnings Ask a doctor before use if you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema a cough occurs with too much phlegm (mucus) Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs 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."]}