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西药 · 美国药品标签原文

Severe Cold and Flu Nighttime Honey

ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL

Severe Cold and Flu Nighttime Honey · Kroger。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

Severe Cold and Flu Nighttime Honey Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl CITRIC ACID MONOHYDRATE FD&C YELLOW NO. 6 GLYCERIN PROPYLENE GLYCOL WATER SODIUM CITRATE SACCHARIN SODIUM SODIUM BENZOATE FD&C RED NO. 40 POLYETHYLENE GLYCOL, UNSPECIFIED D&C YELLOW NO. 10 FD&C GREEN NO. 3 SUCRALOSE SORBITOL SOLUTION XANTHAN GUM DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE DOXYLAMINE SUCCINATE DOXYLAMINE ACETAMINOPHEN ACETAMINOPHEN clear brown color

spl unclassified section

Drug Facts

活性成分 / Active ingredient

Active ingredients (in each 15 mL) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg Phenylephrine HCl 5 mg

用途 / Purpose

Purpose Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant

适应证 / Indications and usage

Uses temporarily relieves common cold/flu symptoms: nasal congestion sinus congestion & pressure cough due to minor throat & bronchial irritation cough to help you sleep minor aches & pains headache fever sore throat runny nose & sneezing reduces swelling of nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage

警告 / Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if adult takes more than 4 doses (30 mL each) in 24 hrs, which is the maximum daily amount for this product child takes more than 4 doses (15 mL each) in 24 hrs, which is the maximum daily amount for this product taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks every day 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. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or 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 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 sleepy

咨询医生 / Ask a doctor

Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes 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 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 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

停用事项 / Stop use

Stop use and ask a doctor if you get nervous, dizzy or sleepless pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults) 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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for 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 only use the dose cup provided do not exceed 4 doses per 24 hrs adults & children 12 yrs & over - 30 mL every 4 hrs children 6 to under 12 yrs - 15 mL every 4 hrs children 4 to under 6 yrs - do not use unless directed by a doctor children under 4 yrs - do not use

其他安全资料 / Other safety information

Other information each 15 mL contains: sodium 14 mg store at no greater than 25℃ and do not refrigerate

辅料 / Inactive ingredients

Inactive ingredients citric acid monohydrate, D&C yellow no. 10, FD&C green no. 3, FD&C red no. 40, FD&C yellow no. 6, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution, sucralose, xanthan gum

questions

Questions or comments? Call 1-800-632-6900

package label principal display panel

767L-Kroger-Severe Cold and Flu Nighttime Honey

来源、版本与许可

资料类型
美国药品标签原文
版本
2 / 20240506
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