{"active_ingredient":["Active Ingredients and Purposes . Active ingredients (in each softgel) Purposes Dextromethorphan HBr 20 mg ...... Cough suppressant Guaifenesin 400 mg ..... Expectorant"],"active_ingredient_table":["
Active ingredients (in each softgel)Purposes
Dextromethorphan HBr 20 mg ......Cough suppressant
Guaifenesin 400 mg .....Expectorant
"],"ask_doctor":["Ask a doctor before use if you have a cough that is accompanied by excessive phlegm (mucus) a persistent or chronic cough 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 do not take more than 6 softgels in a 24 hour period Age Dose adults and children 12 years and older 1 softgel, every 4 hours children under 12 years do not use"],"dosage_and_administration_table":["
AgeDose
adults and children 12 years and older1 softgel, every 4 hours
children under 12 yearsdo not use
"],"effective_time":"20251217","id":"4628aefb-6ec6-af1b-e063-6294a90a1f86","inactive_ingredient":["Inactive ingredients gelatin, glycerin, polyethylene glycol 400, propylene glycol, povidone k30, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide, water"],"indications_and_usage":["Uses Temporarily alleviates common cold/flu symptoms: cough due to minor throat and bronchial irritation helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes 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 right away."],"openfda":{"application_number":["M012"],"brand_name":["Niaflu"],"generic_name":["DEXTROMETHORPHAN HBR, GUAIFENESIN"],"is_original_packager":[true],"manufacturer_name":["Pharmadel LLC"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["55758-507-01"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["55758-507"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1661740"],"spl_id":["4628aefb-6ec6-af1b-e063-6294a90a1f86"],"spl_set_id":["399898f0-e40a-4f5d-e063-6294a90a667d"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN"],"unii":["9D2RTI9KYH","495W7451VQ"]},"other_safety_information":["Other information store between 68-77°F (20-25°C) do not use if blister pack is torn or punctured"],"package_label_principal_display_panel":["Niaflu PDP"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Active ingredients (in each softgel) Purposes Dextromethorphan HBr 20 mg ...... Cough suppressant Guaifenesin 400 mg ..... Expectorant"],"purpose_table":["
Active ingredients (in each softgel)Purposes
Dextromethorphan HBr 20 mg ......Cough suppressant
Guaifenesin 400 mg .....Expectorant
"],"questions":["Questions or comments? +1-866-359-3478 (M-F) 9 AM - 5 PM EST or www.pharmadel.com"],"set_id":"399898f0-e40a-4f5d-e063-6294a90a667d","spl_product_data_elements":["Niaflu Dextromethorphan HBr, Guaifenesin GLYCERIN POLYETHYLENE GLYCOL 400 GELATIN POVIDONE K30 PROPYLENE GLYCOL WATER SORBITOL TITANIUM DIOXIDE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN 1,4-SORBITAN SODIUM HYDROXIDE AC3"],"spl_unclassified_section":["Drug Facts","Dist. by/ por: PHARMADEL LLC New Castle, DE, 19720 +1-866-359-3478"],"stop_use":["Stop use and ask a doctor if cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition."],"version":"2","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 a cough that is accompanied by excessive phlegm (mucus) a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema Stop use and ask a doctor if cough persists for more than 7 days, tends to recur, 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."]}