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spl product data elements
Cold and Flu Nighttime Severe, 24-7 Life acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl SILICON DIOXIDE D&C YELLOW NO. 10 ALUMINUM LAKE FD&C BLUE NO. 1 ALUMINUM LAKE STARCH, CORN CROSPOVIDONE, UNSPECIFIED TALC FERROSOFERRIC OXIDE FD&C YELLOW NO. 6 SODIUM STARCH GLYCOLATE TYPE A POTATO ACETAMINOPHEN ACETAMINOPHEN STEARIC ACID POLYVINYL ALCOHOL, UNSPECIFIED DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN POLYETHYLENE GLYCOL, UNSPECIFIED MAGNESIUM STEARATE POVIDONE, UNSPECIFIED POLYSORBATE 80 DOXYLAMINE SUCCINATE DOXYLAMINE TITANIUM DIOXIDE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE MICROCRYSTALLINE CELLULOSE 44;677
spl unclassified section
Drug Facts Drug Facts
Other information Other information each caplet contains: sodium 3 mg TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number
活性成分 / Active ingredient
Active Ingredients Active Ingredients (in each caplet) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg Phenylephrine HCl 5 mg
用途 / Purpose
Purpose Purpose Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant
适应证 / Indications and usage
Uses Uses temporarily relieves common cold and flu symptoms: minor aches and pains sinus congestion and pressure sore throat fever headache nasal congestion cough due to minor throat and bronchial irritation cough to help you sleep runny nose and sneezing reduces swelling of nasal passages promotes nasal and/or sinus drainage temporarily restores freer breathing through the nose
警告 / Warnings
Warnings Warnings Liver warning Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: blisters rash skin reddening If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning 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 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. if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use Ask a doctor before use if you have liver disease diabetes thyroid disease heart disease glaucoma high blood pressure difficulty in urination due to enlargement of the prostate gland a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin When using this product When using this product do not exceed recommended dosage excitability may occur, especially in children marked drowsiness may occur avoid alcoholic beverages be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness Stop use and ask a doctor Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is presen 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 If pregnant or breast-feeding, ask a health professional before use. 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. Prompt 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 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. 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 Ask a doctor before use if you have liver disease diabetes thyroid disease heart disease glaucoma high blood pressure difficulty in urination due to enlargement of the prostate gland a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus)
咨询医药人员 / Ask a doctor or pharmacist
使用中 / When using
When using this product When using this product do not exceed recommended dosage excitability may occur, especially in children marked drowsiness may occur avoid alcoholic beverages 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 Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is presen 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 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. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt 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 Directions do not take more than directed do not take more than 8 caplets in 24 hours adults and children 12 years and over: take 2 caplets with water every 4 hours children under 12 years: ask a doctor
辅料 / Inactive ingredients
Inactive ingredients Inactive ingredients black iron oxide, corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide
questions
Questions or comments? Questions or comments? 1-877-507-6516
package label principal display panel
Cold & Flu Nighttime Severe, 16ct, 24/7 Life - PDP/Package [24/7 Life logo] Cold & Flu Nighttime Severe Acetaminophen / Pain Reliever/Fever Reducer Dextromethorphan HBr /Cough Suppressant Doxylamine Succinate / Antihistamine Phenylephrine HCl / Nasal Decongestant Relieves: Headache, Fever, Sore Throat, Minor Aches & Pains, Nasal Congestion, Sinus Pressure, Sneezing, Runny Nose, Cough compare to Vicks ® NyQuil ® VapoCOOL™ SEVERE Cold & Flu + Congestion active ingredients* 16 CAPLETS Actual Size [caplet image] PDP/Package
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 2 / 20241216
- 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.

