{"active_ingredient":["Active ingredients (in each caplet) Acetaminophen 325 mg Phenylephrine HCl 5 mg"],"ask_doctor":["Ask a doctor before use if you have heart disease thyroid disease diabetes liver disease high blood pressure difficulty in urination due to enlargement of the prostate gland"],"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 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":"20260709","id":"60356bc7-07d3-4b07-bfa4-f0558e802914","inactive_ingredient":["Inactive ingredients corn starch, croscarmellose sodium, crospovidone, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide, stearic acid"],"indications_and_usage":["Uses temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold: minor aches and pains nasal congestion headache sinus congestion and pressure promotes sinus drainage temporarily reduces fever"],"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 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":{"application_number":["M012"],"brand_name":["Sinus Congestion and Pain Maximum Strength"],"generic_name":["ACETAMINOPHEN, PHENYLEPHRINE HCL"],"is_original_packager":[true],"manufacturer_name":["Rugby Laboratories"],"package_ndc":["0536-1289-35"],"product_ndc":["0536-1289"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1046378"],"spl_id":["60356bc7-07d3-4b07-bfa4-f0558e802914"],"spl_set_id":["fc42e97d-1224-4d29-a55d-1a1885e0bf8f"],"substance_name":["ACETAMINOPHEN","PHENYLEPHRINE HYDROCHLORIDE"],"unii":["362O9ITL9D","04JA59TNSJ"],"upc":["0305361289355"]},"package_label_principal_display_panel":["Principal display panel Rugby ® NDC 0536-1289-35 compare to the active ingredients in Sudafed PE ® Sinus Pressure + Pain* maximum strength sinus congestion & pain acetaminophen 325 mg pain reliever/fever reducer phenylephrine HCl 5 mg nasal decongestant relieves: sinus headache, sinus pressure and nasal congestion non-drowsy actual size 24 caplets Rugby 44-502 Rugby 44-502"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Pain reliever/fever reducer Nasal decongestant"],"questions":["Questions or comments? 1-800-426-9391"],"set_id":"fc42e97d-1224-4d29-a55d-1a1885e0bf8f","spl_product_data_elements":["Sinus Congestion and Pain Maximum Strength Acetaminophen, Phenylephrine HCl ACETAMINOPHEN ACETAMINOPHEN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE STARCH, CORN CROSCARMELLOSE SODIUM CROSPOVIDONE, UNSPECIFIED FD&C YELLOW NO. 6 ALUMINUM LAKE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POVIDONE, UNSPECIFIED SILICON DIOXIDE STEARIC ACID 44;502"],"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 fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition."],"storage_and_handling":["Other information TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number"],"version":"10","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 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. 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 you have heart disease thyroid disease diabetes liver disease high blood pressure difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product do not exceed recommended dosage. Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion 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 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. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"when_using":["When using this product do not exceed recommended dosage."]}