{"active_ingredient":["Active ingredients (in each tablet) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg"],"dosage_and_administration":["Directions • do not take more than directed (see overdose warning) adults and children 12 years and over • take 2 tablets every 4 hours • swallow whole; do not crush, chew or dissolve • do not take more than 10 tablets in 24 hours children under 12 years ask a doctor"],"dosage_and_administration_table":["<table width=\"50%\"><tbody><tr><td styleCode=\"Botrule Lrule Rrule\">adults and children 12 years and over</td><td styleCode=\"Botrule Rrule\">&#x2022; take 2 tablets every 4 hours &#x2022; swallow whole; do not crush, chew or dissolve &#x2022; do not take more than 10 tablets in 24 hours </td></tr><tr><td styleCode=\"Lrule Rrule\">children under 12 years</td><td styleCode=\"Rrule\">ask a doctor</td></tr></tbody></table>"],"effective_time":"20241031","id":"03c670a5-f013-4291-a69b-902cd34715a4","inactive_ingredient":["Inactive ingredients croscarmellose sodium, D&C Yellow #10 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide, sodium starch glycolate, stearic acid, titanium dioxide, triacetin"],"indications_and_usage":["Uses For the temporary relief of the following cold/flu symptoms: • minor aches and pains • headache • sore throat • nasal congestion • cough • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive • temporarily reduces fever"],"keep_out_of_reach_of_children":["Keep out of reach of children. Overdose warning: 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."],"openfda":{"application_number":["M012"],"brand_name":["DoloMax Cold Cough"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["BENARD INDUSTRIES INC"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["55959-133-01"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["55959-133"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1110988"],"spl_id":["03c670a5-f013-4291-a69b-902cd34715a4"],"spl_set_id":["520aee75-8b9a-4dcc-8970-75e122640e91"],"substance_name":["ACETAMINOPHEN","DEXTROMETHORPHAN HYDROBROMIDE","GUAIFENESIN","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["362O9ITL9D","9D2RTI9KYH","495W7451VQ","04JA59TNSJ"]},"package_label_principal_display_panel":["Packaging DoloMaxCold-133"],"purpose":["Purpose Pain Reliever Cough suppressant Expectorant Nasal decongestant"],"questions":["Questions or comments? 1.800.595.0480 Mon-Fri: 9 AM to 4 PM"],"set_id":"520aee75-8b9a-4dcc-8970-75e122640e91","spl_product_data_elements":["DoloMax Cold Cough Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 ALUMINUM LAKE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MALTODEXTRIN MICROCRYSTALLINE CELLULOSE POVIDONE, UNSPECIFIED STARCH, CORN SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A STEARIC ACID TITANIUM DIOXIDE TRIACETIN light yellow"],"spl_unclassified_section":["Drug Facts","SEE NEW WARNINGS INFORMATION & DIRECTIONS Cold/Cough Medicine OTC EXCELLENCE IN NUTRITION TM › Head & Body Aches › Nasal Congestion › Fever › Sore Throat › Cough › Sinus Pain READ AND KEEP CARTON FOR NEW WARNINGS INFORMATION & DIRECTIONS. SEE ACETAMINOPHEN WARNINGS RETAIN CARTON FOR COMPLETE PRODUCT INFORMATION TAMPER EVIDENT: DO NOT USE IF BLISTER IS CUT OR BROKEN Distributed by OTC Pharmaceutical Products 10860 Nw 27th St , Doral , FL 33172 www.otcpharmausa.com"],"storage_and_handling":["Other information • each tablet contains: sodium 2 mg • store at 20°-25°C (68°-77°C)"],"version":"2","warnings":["Warnings Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg acetaminophen) in 24 hours. 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 reactions. Symptoms may include: • skin reddening • blisters • rash If a skin 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. Do not use • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • 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. • if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if • liver disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema • cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are taking blood thinning drug warfarin When using this product do not exceed recommended dose Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • pain, nasal congestion or cough gets worse or lasts more than 7 days • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur • cough comes back or occurs with 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. Overdose warning: 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."]}