{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-06-02", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "spl_product_data_elements": [ "NightTime Sinus Acetaminophen, Doxylamine succinate, Phenylephrine hydrochloride FD&C BLUE NO. 1 GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE PROPYLENE GLYCOL WATER SORBITOL ACETAMINOPHEN ACETAMINOPHEN DOXYLAMINE SUCCINATE DOXYLAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE oblong 665" ], "active_ingredient": [ "Active ingredients (in each softgel) Acetaminophen 325 mg Doxylamine succinate 6.25 mg Phenylephrine HCl 5 mg" ], "purpose": [ "Purpose Pain reliever Antihistamine Nasal decongestant" ], "indications_and_usage": [ "Uses temporarily relieves nasal and sinus symptoms: sinus pain headache nasal and sinus congestion runny nose and sneezing" ], "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 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 & tranquilizers may increase drowsiness Stop use and ask a doctor if redness or swelling is present you get nervous, dizzy or sleepless fever gets worse or lasts more than 3 days new symptoms occur symptoms do not get better within 7 days or are accompanied by a fever If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults and children even if you do not notice any signs or symptoms." ], "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" ], "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" ], "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 & tranquilizers may increase drowsiness" ], "stop_use": [ "Stop use and ask a doctor if redness or swelling is present you get nervous, dizzy or sleepless fever gets worse or lasts more than 3 days new symptoms occur symptoms do not get better within 7 days or are accompanied by a fever" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "overdosage": [ "Overdose warning Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults and children even if you do not notice any signs or symptoms." ], "dosage_and_administration": [ "Directions take only as directed - see Overdose warning do not exceed 4 doses per 24 hrs adults and children 12 years of age and over take 2 softgels with water every 4 hrs Children 4 to under 12 years of age ask a doctor children under 4 years of age do not use when using other Daytime or Nighttime products, carefully read each label to insure correct dosing" ], "dosage_and_administration_table": [ "
adults and children 12 years of age and over take 2 softgels with water every 4 hrs
Children 4 to under 12 years of age ask a doctor
children under 4 years of agedo not use
" ], "storage_and_handling": [ "Other information store at room temperature 15°-30°C (59°-86°F)" ], "inactive_ingredient": [ "Inactive ingredients FD&C Blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, white edible ink Manufactured by: Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. Wuhan, Hubei 430206, China" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - Shipping Label NightTime Sinus Capsules Quantity : 4000 Capsules NDC. No : 53345-031-01 IMPORTANT: Inspect immediate upon receipt. This is a bulk shipment, intended for further processing only. Protect from heat, humidity, and light. Do not refrigerate. CAUTION : \"FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING\" Shipping Label" ], "set_id": "0f3b1404-9252-470a-aa8c-b360c85731f3", "id": "27c7e81e-6413-2983-e063-6394a90a722b", "effective_time": "20241125", "version": "3", "openfda": { "application_number": [ "M012" ], "brand_name": [ "NightTime Sinus" ], "generic_name": [ "ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE" ], "manufacturer_name": [ "Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd." ], "product_ndc": [ "53345-031" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ACETAMINOPHEN", "DOXYLAMINE SUCCINATE", "PHENYLEPHRINE HYDROCHLORIDE" ], "rxcui": [ "1052647" ], "spl_id": [ "27c7e81e-6413-2983-e063-6394a90a722b" ], "spl_set_id": [ "0f3b1404-9252-470a-aa8c-b360c85731f3" ], "package_ndc": [ "53345-031-01" ], "is_original_packager": [ true ], "unii": [ "362O9ITL9D", "V9BI9B5YI2", "04JA59TNSJ" ] } } ] }