{"active_ingredient":["Active ingredients (in each softgel) Acetaminophen 325 mg Doxylamine succinate 6.25 mg Phenylephrine HCl 5 mg"],"ask_doctor":["Ask a doctor before use if you have liver disease heart disease thyroid disease diabetes high blood pressure glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to enlarged prostate gland"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers 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. to make a child sleep"],"dosage_and_administration":["Directions take only as directed do not exceed 4 doses per 24 hrs adults and children 12 yrs & over take 2 softgels with water every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use"],"dosage_and_administration_table":["<table width=\"96%\" cellspacing=\"0\" cellpadding=\"0\"> <tbody> <tr> <td> <paragraph>adults and children 12 yrs &amp; over</paragraph> </td> <td> <paragraph>take 2 softgels with water every 4 hrs</paragraph> </td> </tr> <tr> <td> <paragraph>children 4 to under 12 yrs</paragraph> </td> <td> <paragraph>ask a doctor</paragraph> </td> </tr> <tr> <td> <paragraph>children under 4 yrs</paragraph> </td> <td> <paragraph>do not use</paragraph> </td> </tr> </tbody> </table>"],"effective_time":"20191220","id":"7df87a67-d625-4535-995b-a807adfe3cc8","inactive_ingredient":["Inactive ingredients FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, white edible ink"],"indications_and_usage":["Uses temporarily relieves symptoms due to the common cold minor aches and pains headache fever runny nose and sneezing nasal congestion sinus congestion & pressure temporarily relieves symptoms due to hay fever or other upper respiratory allergies minor aches and pains headache runny nose and sneezing nasal congestion itching of the nose or throat, and itchy, watery eyes sinus congestion & pressure"],"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. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Nite Time Sinus Relief 24 SOFTGELS NDC 51013-156-04 Compare to Vicks ® QlearQuil Nighttime Sinus & Congestion active ingredients * Carton Label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Pain reliever/Fever reducer Antihistamine Nasal decongestant"],"questions":["Questions or comments? Call toll free: 1-855-215-8180"],"set_id":"cd1ec9c1-54da-4b73-8d2c-6b727234142c","spl_product_data_elements":["NiteTime Sinus Relief Acetaminophen, Phenylephrine hydrochloride, Doxylamine succinate ACETAMINOPHEN ACETAMINOPHEN DOXYLAMINE SUCCINATE DOXYLAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE FD&C BLUE NO. 1 GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE PROPYLENE GLYCOL WATER SORBITOL clear oblong PC13"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if 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 you get nervous, dizzy or sleepless"],"storage_and_handling":["Other information store at room temperature 15°-30°C (59°-86°F)"],"version":"2","warnings":["Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily 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. to make a child sleep Ask a doctor before use if you have liver disease heart disease thyroid disease diabetes high blood pressure glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin When using this product do not use more than directed excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives and tranquilizers may increase drowsiness Stop use and ask a doctor if 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 you get nervous, dizzy or sleepless If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms."],"when_using":["When using this product do not use more than directed excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives and tranquilizers may increase drowsiness"]}