{"active_ingredient":["Active ingredients (in each 5 ml) Dextromethorphan HBr, USP 5 mg Guaifenesin, USP 100 mg"],"ask_doctor":["Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema"],"do_not_use":["Do not use 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 do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product."],"dosage_and_administration":["Directions measure only with dosing cup provided keep dosing cup with product ml = milliliter do not take more than 6 doses in any 24-hour period age dose children under 4 years do not use children 4 to under 6 years 5 ml every 4 hours children 6 to under 12 years 10 ml every 4 hours adults and children 12 years and over 20 ml every 4 hours"],"dosage_and_administration_table":["<table width=\"70%\"><col width=\"45%\"/><col width=\"25%\"/><thead><tr><th align=\"left\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><content styleCode=\"bold\">age</content></th><th align=\"left\" styleCode=\"Rrule Botrule Toprule \" valign=\"top\"><content styleCode=\"bold\">dose</content></th></tr></thead><tbody><tr><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph>children under 4 years</paragraph></td><td styleCode=\"Rrule Toprule Botrule \" valign=\"top\"><paragraph>do not use</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>children 4 to under 6 years</paragraph></td><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>5 ml every 4 hours</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>children 6 to under 12 years</paragraph></td><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>10 ml every 4 hours</paragraph></td></tr><tr><td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>adults and children 12 years and over</paragraph></td><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>20 ml every 4 hours</paragraph></td></tr></tbody></table>"],"effective_time":"20240317","id":"13dd51f2-2aca-082e-e063-6294a90a2f4f","inactive_ingredient":["Inactive ingredients anhydrous citric acid, artificial flavor, FD&C blue no. 1, FD&C red no. 40, glycerin, natural flavor, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose"],"indications_and_usage":["Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes"],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M012"],"brand_name":["Childrens Robitussin Cough and Chest Congestion DM"],"generic_name":["DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN"],"is_original_packager":[true],"manufacturer_name":["Haleon US Holdings LLC"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["0031-8715-10"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["0031-8715"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1020138"],"spl_id":["13dd51f2-2aca-082e-e063-6294a90a2f4f"],"spl_set_id":["b9772292-9eb6-47cf-abb8-007c25478090"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN"],"unii":["9D2RTI9KYH","495W7451VQ"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NEW Dosing Information Children's Robitussin ® NOW FOR AGES 4 & OVER Cough & Chest Congestion DM DEXTROMETHORPHAN HBr (Cough Suppressant) GUAIFENESIN (Expectorant) Relieves: ✓ Chest Congestion/Mucus ✓ Cough Non-Drowsy grape flavor 4 FL OZ (118 ml) Principal Display Panel - 118 ml Bottle Carton"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purposes Cough suppressant Expectorant"],"questions":["Questions or comments? call weekdays from 9 AM to 5 PM EST at 1-800-762-4675 For most recent product information, visit www.robitussin.com"],"set_id":"b9772292-9eb6-47cf-abb8-007c25478090","spl_product_data_elements":["Childrens Robitussin Cough and Chest Congestion DM dextromethorphan hydrobromide, guaifenesin ANHYDROUS CITRIC ACID FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL, (R)- WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SUCRALOSE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN purple grape"],"spl_unclassified_section":["Distributed by: Pfizer, Madison, NJ 07940 USA"],"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 5 ml contains: sodium 3 mg store at 20-25°C (68-77°F). Do not refrigerate."],"version":"10","warnings":["Warnings Do not use 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 do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema 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 reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."]}