{"active_ingredient":["Active ingredients (in each caplet) Acetaminophen 325 mg Diphenhydramine HCl 12.5 mg Phenylephrine HCl 5 mg"],"ask_doctor":["Ask a doctor before use if you have • liver disease • glaucoma • thyroid disease • heart disease • diabetes • high blood pressure • difficulty in urination due to enlargement of the prostate gland • a breathing problem such as emphysema or chronic bronchitis"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are • taking the blood thinning drug warfarin • taking sedatives or tranquilizers"],"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. • with any other product containing diphenhydramine, even one used on skin • 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 use more than directed • adults and children 12 years and over • take 2 caplets every 4 hours • do not take more than 10 caplets in 24 hours • children under 12 years: ask a doctor"],"effective_time":"20241209","id":"28db2b26-0d84-844d-e063-6294a90a6852","inactive_ingredient":["Inactive Ingredients microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, polyvinyl pyrrolidone, colloidal silicon dioxide, stearic acid powder, polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc, tartrazine yellow lake, brilliant blue lake, indigo carmine lake"],"indications_and_usage":["Uses • temporarily relieves these symptoms of hay fever and the common cold: • runny nose • sneezing • headache • minor aches and pains • nasal congestion • temporarily relieves these additional symptoms of hay • fever: • itching of the nose or throat • itchy, watery eyes"],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"openfda":{},"package_label_principal_display_panel":["label and carton label carton Label Carton"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Pain reliever Antihistamine Nasal decongestant"],"questions":["Questions or comments? 1-888-333-9792"],"set_id":"7364ffe1-26bf-4d05-94d0-ef946287def9","spl_product_data_elements":["Allergy plus Sinus Headache Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl MICROCRYSTALLINE CELLULOSE STARCH, POTATO CROSCARMELLOSE SODIUM PYRROLIDINE SILICON DIOXIDE STEARIC ACID POLYVINYL ALCOHOL, UNSPECIFIED POLYETHYLENE GLYCOL, UNSPECIFIED TITANIUM DIOXIDE TALC FD&C YELLOW NO. 5 FD&C BLUE NO. 1 FD&C BLUE NO. 2 ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE S504"],"spl_unclassified_section":["Drug Facts Active ingredients (in each caplet) Acetaminophen 325 mg Diphenhydramine HCl 12.5 mg Phenylephrine HCl 5 mg Purpose Pain reliever Antihistamine Nasal decongestant","READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION TAMPER EVIDENT : DO NOT USE IF CARTON IS OPENED OR SAFETY SEAL UNDER CAP IS BROKEN OR MISSING","Distributed By: Spirit Pharmaceuticals, LLC Ronkonkoma, NY 11779 ORIG 05/21 Made in India"],"stop_use":["Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • pain or nasal congestion gets worse or lasts more than 7 days • new symptoms occur • fever gets worse or lasts more than 3 days • redness or swelling is present"],"storage_and_handling":["Other information • store at 25oC (77oF); excursions permitted between 15o-30oC (59o-86oF)"],"version":"5","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 • 3 or more alcoholic drinks every day while using this product • with other drugs containing acetaminophen Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • blisters • rash • skin reddening If a skin reaction occurs, stop use and seek medical help right away."],"when_using":["When using this product • do not exceed recommended dosage • excitability may occur, especially in children • marked drowsiness may occur • alcohol, sedatives, and tranquilizers may increase drowsiness • use caution when driving a motor vehicle or operating machinery • avoid alcoholic beverages"]}