{"active_ingredient":["Active ingredient (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"],"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":"20260722","id":"57355ac1-11fb-8af6-e063-6294a90a01f9","inactive_ingredient":["Inactive ingredients croscarmellose sodium, colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, starch, talc, titanium dioxide"],"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 overdose, get medical help or contact a Poison Control Center right away.1(800)222-1222"],"openfda":{"application_number":["M012"],"brand_name":["Allergy plus Sinus Headache"],"generic_name":["ACETAMINOPHEN 325 MG, DIPHENHYDRAMINE HCL 12.5 MG, PHENYLEPHRINE HCL 5 MG"],"is_original_packager":[true],"manufacturer_name":["Shield Pharmaceuticals Corp"],"package_ndc":["83059-0044-1"],"product_ndc":["83059-0044"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1233575"],"spl_id":["57355ac1-11fb-8af6-e063-6294a90a01f9"],"spl_set_id":["772d0184-8c41-40f1-bbef-7e68692eec66"],"substance_name":["ACETAMINOPHEN","DIPHENHYDRAMINE HYDROCHLORIDE","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["362O9ITL9D","TC2D6JAD40","04JA59TNSJ"]},"other_safety_information":["Other information store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Allergy plus Sinus headache Acetaminophen Diphenhydramine HCl Phenylephrine HCl Pain reliever / Antihistamine / Relieves: runny nose • sneezing • headache • minor aches and pains • hay fever • nasal congestion • itching of the nose or throat • itchy, watery eyes Labe Carton Allergy Sinus Label - India Allergy Sinus Carton - India"],"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? 1-800-373-6981 (toll-free)"],"set_id":"772d0184-8c41-40f1-bbef-7e68692eec66","spl_product_data_elements":["Allergy plus Sinus Headache Acetaminophen 325 mg, Diphenhydramine HCl 12.5 mg, Phenylephrine HCl 5 mg ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE STARCH, CORN CROSCARMELLOSE SODIUM DIBASIC CALCIUM PHOSPHATE DIHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE SILICON DIOXIDE STEARIC ACID TALC TITANIUM DIOXIDE SD18"],"spl_unclassified_section":["Drug Facts","TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.","Shield Pharmaceuticals Corp. Hauppauge, NY 11788"],"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"],"version":"6","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 reactions. Symptoms may include: skin reddening blisters rash hives facial swelling asthma (wheezing) shock If a skin reaction occurs, stop use and seek medical help right away. 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 acetaminophen, ask a doctor or pharmacist."],"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"]}