{"active_ingredient":["Active ingredient (in each liquid-filled capsule) 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":"20251107","id":"430968e1-e0ef-226a-e063-6294a90a4e21","inactive_ingredient":["Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate*, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, polyvinyl pyrrolidone, povidone*, pregelatinized starch, stearic acid powder, talc, titanium dioxide *may contain these ingredients"],"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":["83059-0106-1"],"product_ndc":["83059-0106"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1233575"],"spl_id":["430968e1-e0ef-226a-e063-6294a90a4e21"],"spl_set_id":["093649a4-f968-49bd-83af-bb7e0f448ecf"],"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 / Nasal decongestant Relieves: runny nose • sneezing • headache • minor aches and pains • hay fever • nasal congestion • itching of the nose or throat • itchy, watery eyes Carton 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? 1-800-373-6981 (toll-free)"],"set_id":"093649a4-f968-49bd-83af-bb7e0f448ecf","spl_product_data_elements":["Allergy plus Sinus Headache Acetaminophen 325 mg, Diphenhydramine HCl 12.5 mg, Phenylephrine HCl 5 mg STARCH, CORN CROSCARMELLOSE SODIUM POVIDONE D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C RED NO. 40 MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED SILICON DIOXIDE STEARIC ACID TALC TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE 44;464;SD36"],"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.","Distributed by: Shield Pharmaceuticals Corp. Ronkonkoma, NY 11779"],"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":"2","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"]}