{"active_ingredient":["Active ingredient (per 5mL teaspoonful) Dextromethorphan HBr, USP 10 mg Guaifenesin, USP 100 mg"],"ask_doctor":["Ask Doctor before use if you have • a cough with too much phlegm (mucus) • a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema."],"do_not_use":["Do Not Use if you have ever had an allergic reaction to any of the ingredients in this product."],"dosage_and_administration":["Directions Directions • take every 4 hours as needed, or as directed by a doctor • do not take more than 6 doses in 24 hours • do not exceed recommended dose Adults and children 12 years and over 2 teaspoonsfuls (10 mL) Children under 12 years do not use"],"dosage_and_administration_table":["
Adults and children 12 years and over
2 teaspoonsfuls (10 mL)
Children under 12 years
do not use
"],"effective_time":"20241121","id":"b436ac4b-91da-43d4-9695-b65b7ec0d5e4","inactive_ingredient":["Inactive Ingredients cherry flavor, citric acid, FD&C Red #40, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose, sucrose."],"indications_and_usage":["Uses • temporarily relieves cough due to minor throat and bronchial irritation • helps loosen phlegm (mucus) • helps thin bronchial secretions to make coughs more productive"],"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 (1-800-222-1222) right away"],"openfda":{},"package_label_principal_display_panel":["Package/Label Principal Display Panel MAJOR® NDC 0904-7134-70 Guaifenesin Dextromethorphan Syrup 100 mg/10 mg per 5 mL Delivers 5 mL See insert For Institutional Use Only Alcohol Free Cherry Flavor MAJOR PHARMACEUTICALS Indianapolis, IN 46268 100mg/10mg per 5mL; 5mL cup label","Principal Display Panel Product Insert Guaifenesin Dextromethorphan Syrup 10mg/100mg per 5mL insert"],"pregnancy_or_breast_feeding":["If Pregnancy or Breast Feeding ask a health professional before use."],"purpose":["Purpose Cough suppressant Expectorant"],"questions":["Questions or comments? 1-800-645-2158"],"set_id":"527b944a-b59e-4e83-86d7-69b852e892db","spl_product_data_elements":["Chest Congestion Relief DM Dextromethorphan Hydrobromide, Guaifenesin DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN CITRIC ACID MONOHYDRATE FD&C RED NO. 40 MENTHOL, UNSPECIFIED FORM METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM CITRATE, UNSPECIFIED FORM SUCRALOSE SUCROSE"],"spl_unclassified_section":["Other Information • each teaspoon (5 mL) contains: sodium 2mg • store at room temperature 15°-30°C (59°-86°F) • protect from freezing • do not refrigerate • protect from light • Pharmacist-Preserve and dispense in a tight, light-resistant container with a child resistant cap as defined in the USP • TAMPER-EVIDENT: Do not use if foil seal over bottle opening is torn broken or missing.","This product is not manufactured or distributed by the owner of the registered trademark Robitussin® DM. THIS IS A BULK CONTAINER NOT INTENDED FOR DISPENSING. Distributed by: RUGBY LABORATORIES 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 www.rugbylaboratories.com Packaged and Distributed by FOR INTITUTIONAL USE ONLY: MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 USA Refer to package label for Distributor's NDC Number Rev. 08/20 R-164 Re-order No. 371050"],"spl_unclassified_section_table":["
Rev. 08/20
R-164
Re-order No. 371050
"],"stop_use":["Stop Use and ask a doctor if cough lasts more than 7 days, comes back or is accompanied by fever, rash, or headache that lasts. These could be signs of a serious condition."],"version":"5","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. Do Not Use if you have ever had an allergic reaction to any of the ingredients in this product. Ask Doctor before use if you have • a cough with too much phlegm (mucus) • a 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 headache that lasts. These could be signs of a serious condition. If Pregnancy or Breast Feeding ask a health professional before use."]}