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西药 · 美国药品标签原文

Nighttime Cold/Flu Relief

ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE

Nighttime Cold/Flu Relief · ARMY AND AIR FORCE EXCHANGE SERVICE。此记录对应特定产品,标签收录不代表所有用途获批。

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

Ask a doctor or pharmacist before use if you are ■ taking sedatives or tranquilizers ■ taking the blood thinning drug warfarin

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 &amp; children 12 yrs &amp; 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.
核对原始来源