{"active_ingredient":["Active ingredients (in each caplet) Acetaminophen 325 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg"],"ask_doctor":["Ask a doctor before use if you have • liver disease • heart 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_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin"],"do_not_use":["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."],"dosage_and_administration":["Directions do not take more than directed (see OVERDOSE WARNING) adults and children 12 years and over • take 2 caplets every 4 hours • swallow whole; do not crush, chew or dissolve • do not take more than 10 caplets in 24 hours children under 12 years ask a doctor"],"dosage_and_administration_table":["<table width=\"100%\"><tbody><tr><td>adults and children 12 years and over</td><td>&#x2022; take 2 caplets every 4 hours   &#x2022; swallow whole; do not crush, chew or dissolve   &#x2022; do not take more than 10 caplets in 24 hours </td></tr><tr><td>children under 12 years</td><td>ask a doctor</td></tr></tbody></table>"],"effective_time":"20251031","id":"4276cd88-1e20-408b-e063-6394a90ae904","inactive_ingredient":["Inactive ingredients com starch, crospovidone, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide"],"indications_and_usage":["Uses • temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold: • sinus congestion and pressure • headache • nasal congestion • minor aches and pains • 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."],"openfda":{"application_number":["M012"],"brand_name":["Severe Sinus Congestion and Pain"],"generic_name":["ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE"],"is_original_packager":[true],"manufacturer_name":["Shield Pharmaceuticals Corp"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["83059-0057-1"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["83059-0057"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1243679"],"spl_id":["4276cd88-1e20-408b-e063-6394a90ae904"],"spl_set_id":["c296efd0-5030-4a26-a9b0-e66423d995dc"],"substance_name":["ACETAMINOPHEN","GUAIFENESIN","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["362O9ITL9D","495W7451VQ","04JA59TNSJ"]},"other_safety_information":["Other information • store between 20-25° C (68-77° F)"],"overdosage":["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."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Compare to the active ingredients in Tylenol® Sinus Severe Severe Sinus Congestion & Pain Acetaminophen, Guaifenesin, Phenylephrine HCl Carton Severe Sinus Congestion and Pain Carton"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Pain reliever/fever reducer Expectorant Nasal decongestant"],"questions":["Questions or comments? 1-800-373-6981 (toll-free)"],"set_id":"c296efd0-5030-4a26-a9b0-e66423d995dc","spl_product_data_elements":["Severe Sinus Congestion and Pain Acetaminophen, Guaifenesin, Phenylephrine CROSPOVIDONE STARCH, CORN MAGNESIUM STEARATE MALTODEXTRIN MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL POVIDONE SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A CORN STEARIC ACID SUCRALOSE TALC TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE 44527"],"spl_unclassified_section":["Drug Facts","Distributed by: Shield Pharmaceuticals Corp. Hauppauge, NY 11788"],"stop_use":["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."],"version":"4","warnings":["Warnings Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (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."],"when_using":["When using this product do not exceed recommended dose"]}