说明与适用边界
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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
活性成分 / Active ingredient
Active ingredients (in each softgel) Acetaminophen 325 mg Doxylamine succinate 6.25 mg Phenylephrine HCl 5 mg
用途 / Purpose
Purpose Pain reliever Antihistamine Nasal decongestant
适应证 / Indications and usage
Uses temporarily relieves nasal and sinus symptoms: sinus pain headache nasal and sinus congestion runny nose and sneezing
警告 / 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.
禁用事项 / 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
咨询医生 / Ask a 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
咨询医药人员 / Ask a doctor or pharmacist
使用中 / 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
停用事项 / 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
孕哺期 / Pregnancy or breastfeeding
If pregnant or breast-feeding, ask a health professional before use.
儿童安全 / Keep out of reach of children
Keep out of reach of children.
过量 / 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.
用法用量原文 / 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
<table ID="id_d9660161-7d96-40b8-a55f-2d685e60bfc0" width="435px" border="single"><col width="25.3%"/><col width="80.7%"/><tbody><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule"><paragraph>adults and children 12 years of age and over</paragraph></td><td align="left" styleCode="Botrule Rrule"> take 2 softgels with water every 4 hrs</td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule"><paragraph>Children 4 to under 12 years of age</paragraph></td><td align="left" styleCode="Botrule Rrule"> ask a doctor</td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule"><paragraph>children under 4 years of age</paragraph></td><td align="left" styleCode="Botrule Rrule"><content styleCode="bold"/>do not use </td></tr></tbody></table>
储存 / Storage and handling
Other information store at room temperature 15°-30°C (59°-86°F)
辅料 / Inactive ingredients
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
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 3 / 20241125
- 获取时间
- 2026-10-08
- 许可
- openFDA public data; retain original label attribution. See 查看来源 and dataset source notices. Public access does not imply approval or unrestricted rights to every submitted label.

