说明与适用边界
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spl product data elements
Nighttime Cold/Flu Relief ACETAMINOPHEN, DEXTROMETHORPHAN HBr, DOXYLAMINE SUCCINATE D&C YELLOW NO. 10 FD&C BLUE NO. 1 GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE PROPYLENE GLYCOL WATER SORBITOL SORBITAN TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE 603
活性成分 / Active ingredient
Drug Facts Active ingredients (in each Softgel) Acetaminophen ................325 mg Dextromethorphan HBr ......15 mg Doxylamine succinate .........6.25 mg
用途 / Purpose
Purpose Acetaminophen ........................Pain reliever/Fever reducer Dextromethorphan HBr .............Cough suppressant Doxylamine succinate ............... Antihistamine
适应证 / Indications and usage
Uses temporarily relieves common cold/flu symptoms: ■ cough due to minor throat & bronchial irritation ■ sore throat ■ headache ■ minor aches and pain ■ fever ■ runny nose and sneezing
警告 / Warnings
Warnings Liver warning : This product contains acetaminophen. Severe liver damage may occur if you take ■ more than 4doses in 24 hrs, 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 skin reaction occurs, stop use and seek medical help right away. Sore throat warning : If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.
禁用事项 / Do not use
Do not use: ■ with any other products 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 ■ glaucoma ■ cough that occurs with too much phlegm (mucus) ■ a breathing problem or chronic cough that lasts or as occurs with smoking, asthma chronic bronchitis or emphysema ■ trouble urinating due to an enlarged prostate gland
咨询医药人员 / Ask a doctor or pharmacist
使用中 / When using
When using this produc t, 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
停用事项 / Stop use
Stop use and ask a doctor if ■ pain or cough 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 ■ cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
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. In case of overdose, get medical help or contact a Poison Control Center right away.
过量 / Overdosage
In case of accidental overdose , get medical help or contact a Poison Control center right away. Quick medical attention is critical for adults as well as 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 Warning) ■ do not exceed 4 doses per 24 hours adults & children 12 yrs & over 2 soft gels with water every 6 hours children 4 to under 12 years: ask a doctor children under 4 years: do not use ■ When using other Daytime or Nighttime products, carefully read each label to ensure correct dosing.
dosage and administration table
<table width="200px"><caption/><tbody><tr><td><paragraph>adults & children 12 yrs & over </paragraph><paragraph/></td><td><paragraph>2 soft gels with water every 6 hours</paragraph><paragraph/><paragraph/></td></tr><tr><td><paragraph>children 4 to under 12 years:</paragraph><paragraph/></td><td><paragraph>ask a doctor</paragraph><paragraph/><paragraph/><paragraph/></td></tr><tr><td>children under 4 years:</td><td><paragraph> do not use</paragraph><paragraph/></td></tr></tbody></table>
其他安全资料 / Other safety information
Other information ■ Store at room temperature 20-25º C (68-77º F) ■ avoid excessive heat
辅料 / Inactive ingredients
Inactive ingredients D&C Yellow # 10, FD&C Blue # 1, Gelatin, Glycerin, Polyethylene glycol, Povidone, Propylene glycol, Purified water, Sorbitol sorbitan solution, Titanium dioxide.
questions
Questions? Call Weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944
package label principal display panel
Product Label: exchange select NightTime Cold/Flu Relief exchange select Nighttime Cold/Flu Relief 24 Softgels Manufactured For Your Military Exchange By AptaPharma Inc., 1533 Union Avenue, Pennsauken, NJ 08110 1-877-798-5944 aptapharma.com res 603-03 crtn
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 4 / 20251219
- 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.

