{"active_ingredient":["Active ingredients (in each caplet) Acetaminophen 500 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 difficulty in urination due to enlargement of the prostrate 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 allergic to acetaminophen or any of the inactive ingredients in this product if you are now taking 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."],"dosage_and_administration":["Directions do not take more than directed (see overdose warning )​ adults and children 12 years and older: take 2 caplets every 6 hours as needed swallow whole - do not crush, chew or dissolve do not take more than 8 caplets in 24 hours children under 12 years: ask a doctor"],"effective_time":"20191209","id":"994f716f-25e8-7007-e053-2995a90a308e","inactive_ingredient":["Inactive ingredients Croscarmellose sodium, crospovidone, FD&C red # 40, FD&C yellow # 6, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, silicon dioxide, stearic acid, titanium dioxide, triacetin."],"indications_and_usage":["Uses for the temporary relief of: sinus congestion and pressure headache nasal congestion minor aches and pains helps decongest sinus openings and passages promotes sinus drainage helps clear nasal passages temporarily reduces fever"],"keep_out_of_reach_of_children":["Keep out of reach of children. 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."],"openfda":{},"package_label_principal_display_panel":["SEE NEW WARNINGS INFORMATION SINE OFF® MAXIMUM STRENGTH Non-Drowsy Relief of Sinus Headache Pain / Fever Sinus Pressure Nasal Congestion Contains no ingredient made from a gluten-containing grain (wheat, barley, rye). Each Caplet Contains: Acetaminophen 500mg....Pain reliever/fever reducer Phenylephrine HCl 5mg.....Nasal decongestant 24 Caplets 51645-269 SineOff Jul 2018"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purposes Pain reliever / fever reducer Nasal decongestant"],"questions":["Questions? If you have any questions or comments, or to report an adverse event, please contact 1-888-876-6898 ."],"set_id":"e37237f4-20a0-4599-84c8-d96c62062861","spl_product_data_elements":["SINE OFF MAXIMUM STRENGTH ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE HYPROMELLOSE, UNSPECIFIED CROSCARMELLOSE SODIUM CROSPOVIDONE FD&C RED NO. 40 FD&C YELLOW NO. 6 MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POVIDONE STARCH, CORN PROPYLENE GLYCOL SILICON DIOXIDE STEARIC ACID TITANIUM DIOXIDE TRIACETIN ACETAMINOPHEN ACETAMINOPHEN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE Capsule Shaped Tablet Sine;Off;PE"],"spl_unclassified_section":["Drug Facts","Other information store at room temprature in a dry place avoid excessive heat and humidity retain carton for complete product information","DO NOT USE IF CARTON IS OPEN OR IF SEALED BLISTER UNITS ARE BROKEN OR DAMAGED. Manufactured by: Gemini Pharmaceuticals, Inc. Commack, NY 11725"],"stop_use":["Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness swelling is present new symptoms occur These could be signs of a serious condition."],"version":"4","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 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 allergic to acetaminophen or any of the inactive ingredients in this product if you are now taking 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. Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes difficulty in urination due to enlargement of the prostrate 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 occurs pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness 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. 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."],"when_using":["When using this product do not exceed recommended dosage."]}