{"active_ingredient":["Active ingredients (in each SOFTGEL) Acetaminophen 325 mg Dextromethorphan hydrobromide 10 mg Phenylephrine hydrochloride 5 mg","Active ingredeints in each softgel ACETAMINOPHEN 325 mg Dextromethorphan Hydrobromide 10 mg Doxylamine Succinate 6.25 mg Phenylephrine HCl 5 mg"],"dosage_and_administration":["Directions · do not take more than the recommended dose · adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 10 capsules in 24 hours or as directed by a doctor. · children under 12 years: do not use","Directions · do not take more than the recommended dose · adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 10 capsules in 24 hours or as directed by a doctor. · children under 12 years: do not use"],"effective_time":"20250215","id":"2e2cfbf4-ca68-d248-e063-6394a90a13a6","inactive_ingredient":["Inactive ingredients: FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide","Inactive ingredients: FD&C Blue #1,gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, , sorbitol sorbitan solution, titanium dioxide"],"indications_and_usage":["Pain Reliever-Fever Reducer Cough Suppressant Antihistamine Nasal Decongestant Nasal Congestion Headache & Body Ache Cough Runny Nose Sore Throat","Uses · temporarily relieves these symptoms due to a cold or flu: · minor aches and pains · headache · cough · sore throat · nasal and sinus congestion · temporarily reduces fever"],"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) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.","Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"openfda":{"application_number":["M012"],"brand_name":["MAXIMUM STRENGTH DAY-NIGHT COLD AND FLU FORMULA"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE HCL"],"is_original_packager":[true],"manufacturer_name":["FAMILY DOLLAR"],"package_ndc":["55319-935-02","55319-933-22","55319-934-08"],"product_ndc":["55319-935"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1086997","1297288","2634363"],"spl_id":["2e2cfbf4-ca68-d248-e063-6394a90a13a6"],"spl_set_id":["aa8f6dd0-d19f-0c10-e053-2a95a90a1e8a"],"upc":["0032251628559"]},"package_label_principal_display_panel":["20ct"],"purpose":["Purposes: Pain reliever/fever reducer Cough suppressant Nasal decongestant","Pain Reliever-Fever Reducer Cough Suppressant Antihistamine /Nasal Decongestant"],"set_id":"aa8f6dd0-d19f-0c10-e053-2a95a90a1e8a","spl_product_data_elements":["MAXIMUM STRENGTH DAY-NIGHT COLD AND FLU FORMULA ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE HCL MAXIMUM STRENGHT DAY COLD AND FLU FORMULA ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE HCL SHELLAC TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE FD&C YELLOW NO. 6 FD&C RED NO. 40 PROPYLENE GLYCOL WATER SORBITOL POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE GELATIN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GLYCERIN 70 MAXIMUM STRENTH NIGHT COLD AND FLU FORMULA ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE SORBITOL TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN DOXYLAMINE SUCCINATE DOXYLAMINE FD&C BLUE NO. 1 POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE PROPYLENE GLYCOL GELATIN GLYCERIN WATER SHELLAC 72"],"spl_unclassified_section":["DRUG FACTS - DAY MAXIMUM STRENGTH COLD AND FLU (633T) DAY MAXIMUM STRENGTH COLD AND FLU","DRUG FACTS - NIGHT MAXIMUM STRENGTH COLD AND FLU NIGHT MAXIMUM STRENGTH COLD AND FLU"],"version":"4","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take · more than 4,000 mg of acetaminophen in 24 hours · with other drugs containing acetaminophen · 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include: · skin reddening · blisters · rash · hives · facial swelling · asthma (wheezing) · shock If a skin or general allergic reaction occurs, stop use and seek medical help right away. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.","Warnings Liver warning : This product contains acetaminophen. Severe liver damage may occur if you take · more than 4,000 mg of acetaminophen in 24 hours · with other drugs containing acetaminophen · 3 or more aloholic drinks every day while using this product l Allergy alert: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include: · skin reddening · blisters · rash · hives · facial swelling · asthma (wheezing) · shock If a skin or general allergic reaction occurs, stop use and seek medical help right away. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly."]}