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spl product data elements
SEVERE COLD AND FLU acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ANHYDROUS CITRIC ACID D&C YELLOW NO. 10 EDETATE DISODIUM FD&C GREEN NO. 3 FD&C RED NO. 40 FD&C YELLOW NO. 6 GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM BENZOATE SODIUM CHLORIDE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SOLUTION SUCRALOSE XANTHAN GUM
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 and pressure • cough due to minor throat and bronchial irritation • cough to help you sleep • minor aches and pains • headache • fever • sore throat • runny nose and 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 4,000 mg of acetaminophen in 24 hours • child takes more than 5 doses in 24 hours • 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. 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 • if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have • liver disease • heart disease • glaucoma • thyroid disease • diabetes • high blood pressure • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (mucus) • a breathing problem such as emphysema or chronic bronchitis • persistent or chronic cough such as occurs with smoking, asthma, or emphysema Ask a doctor or pharmacist before use if you are • taking the blood thinning drug warfarin • taking sedatives or tranquilizers 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 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. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for 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 sleepy • if you have ever had an allergic reaction to this product or any of its ingredients
咨询医生 / Ask a doctor
Ask a doctor before use if you have • liver disease • heart disease • glaucoma • thyroid disease • diabetes • high blood pressure • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (mucus) • a breathing problem such as emphysema or chronic bronchitis • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
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, 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. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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 – see Overdose warning • 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 ask a doctor children under 4 yrs do not use
dosage and administration table
<table styleCode="Noautorules" width="100%"><col width="47%"/><col width="51%"/><tbody><tr><td styleCode="Rrule Botrule Toprule " valign="top"><list listType="unordered"><item><caption> </caption>adults & children 12 yrs & over</item></list></td><td styleCode="Botrule Lrule Toprule " valign="top"><list listType="unordered"><item><caption> </caption>30 mL every 4 hrs</item></list></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><list listType="unordered"><item><caption> </caption>children 6 to under 12 yrs</item></list></td><td styleCode="Lrule Toprule Botrule " valign="top"><list listType="unordered"><item><caption> </caption>15 mL every 4 hrs</item></list></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><list listType="unordered"><item><caption> </caption>children 4 to under 6 yrs</item></list></td><td styleCode="Lrule Toprule Botrule " valign="top"><list listType="unordered"><item><caption> </caption>ask a doctor</item></list></td></tr><tr><td styleCode="Rrule Botrule Toprule " valign="top"><list listType="unordered"><item><caption> </caption>children under 4 yrs</item></list></td><td styleCode="Botrule Lrule Toprule " valign="top"><list listType="unordered"><item><caption> </caption>do not use</item></list></td></tr></tbody></table>
其他安全资料 / Other safety information
Other information • each 15 mL contains: sodium 15 mg • store at 20-25°C (68-77°F)
辅料 / Inactive ingredients
Inactive ingredients anhydrous citric acid, D&C yellow #10, edetate disodium, FD&C green #3, FD&C red #40, FD&C yellow #6, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose, xanthan gum
questions
Questions? 1-800-719-9260
package label principal display panel
Package/Label Principal Display Panel CVS ™ Honey Flavor Nighttime SEVERE COLD & FLU Acetaminophen Pain Reliever, Fever Reducer Phenylephrine HCl Nasal Decongestant Dextromethorphan HBr Cough Suppressant Doxylamine Succinate Antihistamine Compare to Vicks ® NyQuil ® Severe Honey Flavor active ingredients Relieves: Fever, Sore throat, Minor aches & pains, Nasal congestion, Sinus pressure, Sneezing, Runny nose, Cough 12 FL OZ (355 mL) cvs-severe-cold-&-flu-container-image.jpg
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 2 / 20260126
- 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.

