{"active_ingredient":["Active ingredients (in each extended-release tablet) Dextromethorphan HBr 60 mg Guaifenesin 1200 mg"],"ask_doctor":["Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough accompanied by too much phlegm (mucus)"],"do_not_use":["Do not use for children under 12 years of age 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 do not crush, chew, or break tablet take with a full glass of water this product can be administered without regard for timing of meals adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours children under 12 years of age: do not use"],"effective_time":"20240407","id":"158a1612-05f6-cc2e-e063-6294a90ab9ef","inactive_ingredient":["Inactive ingredients carbomer homopolymer type B, copovidone, D&C yellow #10 aluminum lake, hypromellose, magnesium hydroxide, magnesium stearate, microcrystalline cellulose, silicon dioxide"],"indications_and_usage":["Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing 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":["ANDA207602"],"brand_name":["Robitussin Maximum Strength 12 Hour Cough and Mucus Relief"],"generic_name":["DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN"],"is_original_packager":[true],"manufacturer_name":["Haleon US Holdings LLC"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["0031-8765-04","0031-8765-08","0031-8765-16"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["0031-8765"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1099074"],"spl_id":["158a1612-05f6-cc2e-e063-6294a90ab9ef"],"spl_set_id":["96409b52-b0ec-444b-bc39-fd41070e9855"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN"],"unii":["9D2RTI9KYH","495W7451VQ"]},"package_label_principal_display_panel":["Principal Display Panel NEW! Robitussin ® MAXIMUM STRENGTH 12 Hour Cough & Mucus Relief EXTENDED-RELEASE TABLETS GUAIFENESIN & DEXTROMETHORPHAN HYDROBROMIDE 1200 mg/60 mg EXTENDED-RELEASE TABLETS Expectorant & Cough Suppressant Actual Size ✓Controls Cough ✓Thins & Loosens Mucus 8 EXTENDED-RELEASE TABLETS Robitussin 12 Hr Cough 1200mg/60mg ER Tabs"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purposes Cough suppressant Expectorant"],"questions":["Questions? call weekdays from 9 AM to 5 PM EST at 1-800-762-4675"],"set_id":"96409b52-b0ec-444b-bc39-fd41070e9855","spl_product_data_elements":["Robitussin Maximum Strength 12 Hour Cough and Mucus Relief Dextromethorphan Hydrobromide, Guaifenesin CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) COPOVIDONE K25-31 D&C YELLOW NO. 10 HYPROMELLOSE, UNSPECIFIED MAGNESIUM HYDROXIDE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SILICON DIOXIDE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN 2424"],"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 occurs with fever, rash, or persistent headache. These could be signs of a serious illness."],"storage_and_handling":["Other information each tablet contains: magnesium 25 mg store between 20-25°C (68-77°F)"],"version":"5","warnings":["Warnings Do not use for children under 12 years of age 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 persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough accompanied by too much phlegm (mucus) When using this product do not use more than directed Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness. 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)."],"when_using":["When using this product do not use more than directed"]}