{"active_ingredient":["Active ingredient (in each 5 mL) Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide, USP"],"ask_doctor":["Ask a doctor before use if you have chronic cough that lasts as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus)"],"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 shake bottle well before use measure only with dosing cup provided. Do not use dosing cup with other products dose as follows or as directed by doctor mL = milliliter adults and children 12 years of age and over 10 mL every 12 hours, not to exceed 20 mL in 24 hours children 6 to under 12 years of age 5 mL every 12 hours, not to exceed 10 mL in 24 hours children 4 to under 6 years of age 2.5 mL every 12 hours, not to exceed 5 mL in 24 hours children under 4 years of age do not use"],"dosage_and_administration_table":["
adults and children 12 years of age and over10 mL every 12 hours, not to exceed 20 mL in 24 hours
children 6 to under 12 years of age5 mL every 12 hours, not to exceed 10 mL in 24 hours
children 4 to under 6 years of age2.5 mL every 12 hours, not to exceed 5 mL in 24 hours
children under 4 years of agedo not use
"],"effective_time":"20240408","id":"159a0a07-055f-e1e2-e063-6394a90a9a37","inactive_ingredient":["Inactive ingredients (Grape flavor) D&C red no. 30, FD&C blue no. 1, flavor, glycerin, high fructose corn syrup, methylparaben, polysorbate 80, polyvinyl acetate, povidone, propylparaben, purified water, sodium metabisulfite, sodium polystyrene sulfonate, sucrose, tartaric acid, tragacanth gum, triacetin, xanthan gum","Inactive ingredients (Orange flavor) D&C red no. 30, D&C yellow no. 10, flavor, glycerin, high fructose corn syrup, methylparaben, polysorbate 80, polyvinyl acetate, povidone, propylparaben, purified water, sodium metabisulfite, sodium polystyrene sulfonate, sucrose, tartaric acid, tragacanth gum, triacetin, xanthan gum"],"indications_and_usage":["Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the impulse to cough to help you get to sleep"],"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 1-800-222-1222."],"openfda":{"application_number":["ANDA091135"],"brand_name":["Robitussin 12 Hour Cough Relief"],"generic_name":["DEXTROMETHORPHAN POLISTIREX"],"is_original_packager":[true],"manufacturer_name":["Haleon US Holdings LLC"],"package_ndc":["0031-8655-10","0031-8754-15","0031-8753-03","0031-8755-15"],"product_ndc":["0031-8655","0031-8754","0031-8753","0031-8755"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1373045"],"spl_id":["159a0a07-055f-e1e2-e063-6394a90a9a37"],"spl_set_id":["5d12a1b8-f1fb-41ca-9a4f-0595a585cbb5"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE"],"unii":["9D2RTI9KYH"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Robitussin ® EXTENDED-RELEASE 12 Hour Cough Relief DEXTROMETHORPHAN POLISTIREX EXTENDED- RELEASE ORAL SUSPENSION (Cough Suppressant) 12 Hour Cough Relief DAY or NIGHT Orange Flavored Liquid Alcohol-Free 3 FL OZ (89 mL) Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions Robitussin 12 HR Orange 3 FL OZ(89 mL)","PRINCIPAL DISPLAY PANEL NEW SIZE! Robitussin ® EXTENDED-RELEASE 12 Hour Cough Relief DEXTROMETHORPHAN POLISTIREX EXTENDED- RELEASE ORAL SUSPENSION (Cough Suppressant) 12 Hour Cough Relief DAY or NIGHT Orange Flavored Liquid Alcohol-Free 5 FL OZ (148 mL) Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions Robitussin 12 HR Orange 5 FL OZ (148 mL)","PRINCIPAL DISPLAY PANEL Robitussin ® EXTENDED-RELEASE 12 Hour Cough Relief DEXTROMETHORPHAN POLISTIREX EXTENDED- RELEASE ORAL SUSPENSION (Cough Suppressant) 12 Hour Cough Relief DAY or NIGHT Grape Flavored Liquid Alcohol-Free 3 FL OZ (89 mL) Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions Robitussin 12 HR Grape 3 FL OZ (89 mL)","PRINCIPAL DISPLAY PANEL NEW SIZE! Robitussin ® EXTENDED-RELEASE 12 Hour Cough Relief DEXTROMETHORPHAN POLISTIREX EXTENDED- RELEASE ORAL SUSPENSION (Cough Suppressant) 12 Hour Cough Relief DAY or NIGHT Grape Flavored Liquid Alcohol-Free 5 FL OZ (148 mL) Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions Robitussin 12 HR Grape 5 FL OZ (148 mL)"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Cough suppressant"],"questions":["Questions? call weekdays from 9 AM to 5 PM EST at 1-800-762-4675 . You may also report side effects to this number. For most recent product information, visit www.robitussin.com"],"set_id":"5d12a1b8-f1fb-41ca-9a4f-0595a585cbb5","spl_product_data_elements":["Robitussin 12 Hour Cough Relief dextromethorphan polistirex POLISTIREX D&C RED NO. 30 D&C YELLOW NO. 10 GLYCERIN HIGH FRUCTOSE CORN SYRUP METHYLPARABEN POLYSORBATE 80 POLYVINYL ACETATE POVIDONE, UNSPECIFIED PROPYLPARABEN SODIUM METABISULFITE SODIUM POLYSTYRENE SULFONATE SUCROSE TARTARIC ACID TRAGACANTH TRIACETIN WATER XANTHAN GUM DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN Robitussin 12 Hour Cough Relief dextromethorphan polistirex POLISTIREX D&C RED NO. 30 D&C YELLOW NO. 10 GLYCERIN HIGH FRUCTOSE CORN SYRUP METHYLPARABEN POLYSORBATE 80 POLYVINYL ACETATE POVIDONE, UNSPECIFIED PROPYLPARABEN SODIUM METABISULFITE SODIUM POLYSTYRENE SULFONATE SUCROSE TARTARIC ACID TRAGACANTH TRIACETIN WATER XANTHAN GUM DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN Robitussin 12 Hour Cough Relief dextromethorphan polistirex POLISTIREX D&C RED NO. 30 FD&C BLUE NO. 1 GLYCERIN HIGH FRUCTOSE CORN SYRUP METHYLPARABEN POLYSORBATE 80 POLYVINYL ACETATE POVIDONE, UNSPECIFIED PROPYLPARABEN SODIUM METABISULFITE SODIUM POLYSTYRENE SULFONATE SUCROSE TARTARIC ACID TRAGACANTH TRIACETIN WATER XANTHAN GUM DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN Robitussin 12 Hour Cough Relief dextromethorphan polistirex POLISTIREX D&C RED NO. 30 FD&C BLUE NO. 1 GLYCERIN HIGH FRUCTOSE CORN SYRUP METHYLPARABEN POLYSORBATE 80 POLYVINYL ACETATE POVIDONE, UNSPECIFIED PROPYLPARABEN SODIUM METABISULFITE SODIUM POLYSTYRENE SULFONATE SUCROSE TARTARIC ACID TRAGACANTH TRIACETIN WATER XANTHAN GUM DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN"],"spl_unclassified_section":["Distributed by: Pfizer, Madison, NJ 07940 USA"],"stop_use":["Stop use and ask a doctor if side effects occur. You may report side effects to FDA at 1-800-FDA-1088. cough lasts more than 7 days, cough comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition."],"storage_and_handling":["Other information each 5 mL contains: sodium 5 mg store at 20-25°C (68-77°F) dosing cup provided"],"version":"7","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. Allergy Alert Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions. Ask a doctor before use if you have chronic cough that lasts as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus) Stop use and ask a doctor if side effects occur. You may report side effects to FDA at 1-800-FDA-1088. cough lasts more than 7 days, cough comes back, or occurs with fever, rash, or headache that lasts. 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 1-800-222-1222."]}