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spl product data elements
Daytime and Nighttime Cold and Flu Kit Daytime and Nighttime Cold and Flu Kit Daytime Cold and Flu Daytime Cold and Flu ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN GLYCERIN POLYETHYLENE GLYCOL 400 POVIDONE K12 PROPYLENE GLYCOL WATER SORBITOL P41 Nighttime Cold and Flu Relief Acetaminophen ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE D&C YELLOW NO. 10 FD&C BLUE NO. 1 GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE PROPYLENE GLYCOL WATER SORBITOL Clear PC10 OBLONG
活性成分 / Active ingredient
Active ingredient(s) DAYTIME ONLY Acetaminophen 325mg Dextromethorphan HBr 10mg NIGHTTIME ONLY Acetaminophen 325mg Dextromethorphan HBr 15mg Doxylamine succinate 6.25mg
用途 / Purpose
Purpose DAYTIME ONLY Pain reliever/fever reducer Cough suppressant NIGHTTIME ONLY Pain reliever/fever reducer Cough suppressant Antihistamine
适应证 / Indications and usage
Use(s) DAYTIME ONLY temporarily relieves these symptoms due to a cold or flu: cough sore throat headache minor aches and pains temporarily reduces fever NIGHTTIME ONLY temporarily relieves common cold/flu symptoms: • cough due to minor throat & bronchial irritation • sore throat • headache • minor aches & pains • fever • runny nose & sneezing
警告 / Warnings
Warnings DAYTIME Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 10 softgels in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product NIGHTTIME Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: • more than 4 doses in 24 hours, which is the maximum daily amount for this product • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product DAYTIME AND NIGHTTIME 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, occurs with or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use if you have DAYTIME ONLY • 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 in children under 12 years of age NIGHTTIME ONLY • 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 sleep Ask a doctor before use if you DAYTIME ONLY • liver disease • heart disease • thyroid disease • diabetes • high blood pressure • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (mucus) • persistent or chronic cough as occurs with smoking, asthma, or emphysema NIGHTTIME ONLY • 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 enlarged prostate gland Ask a doctor or pharmacist before use if DAYTIME ONLY taking the blood thinning drug warfarin. NIGHTTIME ONLY • taking sedatives or tranquilizers • taking the blood thinning drug warfarin When using this product DAYTIME ONLY do not exceed recommended dosage. NIGHTTIME ONLY • 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 & tranquilizers may increase drowsiness Stop use and ask a doctor if DAYTIME ONLY Stop use and ask a doctor if nervousness, dizziness or sleeplessness occurs pain, cough gets worse or last 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. NIGHTTIME ONLY • 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. If pregnant or breastfeeding, ask a health professional before use. 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.
禁用事项 / Do not use
Do not use if you have DAYTIME ONLY • 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 in children under 12 years of age NIGHTTIME ONLY • 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 sleep
咨询医生 / Ask a doctor
Ask a doctor before use if you DAYTIME ONLY • liver disease • heart disease • thyroid disease • diabetes • high blood pressure • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (mucus) • persistent or chronic cough as occurs with smoking, asthma, or emphysema NIGHTTIME ONLY • 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 enlarged prostate gland
咨询医药人员 / Ask a doctor or pharmacist
使用中 / When using
When using this product DAYTIME ONLY do not exceed recommended dosage. NIGHTTIME ONLY • 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 & tranquilizers may increase drowsiness
停用事项 / Stop use
Stop use and ask a doctor if DAYTIME ONLY Stop use and ask a doctor if nervousness, dizziness or sleeplessness occurs pain, cough gets worse or last 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. NIGHTTIME ONLY • 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 breastfeeding, 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 DAYTIME ONLY Take only as directed Do not exceed 4 doses in 24hours Adults and children 12 yrs & over: 2 softgels with water every 4 hrs Children under 12 yrs : ask a doctor Children under 4 yrs: do not use NIGHTTIME ONLY Take only as directed Do not exceed 4 doses in 24hours Adults and children 12 yrs & over: 2 softgels with water every 6 hrs Children 4 to under 12 yrs: ask a doctor Children under 4 yrs: do not use
spl unclassified section
Other information store at room temperature 20-25 °C (68-77° F) Avoid excessive heat do not use if blister unit is torn or open
辅料 / Inactive ingredients
Inactive ingredients DAYTIME ONLY FD&C Red #40, FD&C Yellow #6, Gelatin, Glycerin, Polyethylene Glycol 400, Povidone K12, Propylene Glycol, Purified water, Sorbitol Sorbitan Solution, White Edible Ink NIGHTTIME ONLY D&C Yellow #10, FD&C Blue #1, Gelatin, Glycerin, Polyethylene Glycol, Povidone, Propylene Glycol, Purified Water, Sorbitol Sorbitan Solution, White Edible Ink
questions
Questions/Comments Call 1-888-952-0050 (Monday-Friday 9 AM – 5 PM EST)
package label principal display panel
Principal Display Panel Daytime and Nighttime Cold and Flu Daytime and Nighttime Cold and Flu
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 5 / 20260306
- 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.

