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spl product data elements
Daytime Nighttime Ultra Concentrated Cold and Flu Daytime - Acetaminophen, Dextromethrophan HBr, Phenylephrine HCL and Nighttime - Acetaminophen, Dextromethrophan HBr, Doxylamine succinate Daytime Ultra Concentrated Cold and Flu Acetaminophen, Dextromethrophan HBr, Phenylephrine HCl SORBITAN PROPYLENE GLYCOL SHELLAC PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE MICA FD&C YELLOW NO. 6 ALUMINUM LAKE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE WATER TITANIUM DIOXIDE GELATIN SORBITOL GLYCERIN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN ACETAMINOPHEN ACETAMINOPHEN 151 Nighttime Ultra Concentrated Cold and Flu Acetaminophen, Dextromethorphan HBr, Doxylamine succinate SORBITAN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE D&C YELLOW NO. 10 SORBITOL MICA GLYCERIN WATER GELATIN TITANIUM DIOXIDE FD&C BLUE NO. 1 SHELLAC PROPYLENE GLYCOL DOXYLAMINE SUCCINATE DOXYLAMINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN ACETAMINOPHEN ACETAMINOPHEN 152
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Drug Facts Daytime Ultra Concentrated Cold & Flu
Drug Facts Nighttime Ultra Concentrated Cold & Flu
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.
活性成分 / Active ingredient
Active ingredient (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg Purpose Pain reliever/fever reducer Cough suppressant Nasal decongestant
Active ingredient (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg
用途 / Purpose
Purpose Pain reliever/fever reducer Cough suppressant Nasal decongestant
Purpose Pain reliever/fever reducer Cough suppressant Antihistamine
适应证 / Indications and usage
Uses temporarily relieves common cold/flu symptoms: • nasal congestion • cough due to minor throat & bronchial irritation • sore throat • headache • minor aches & pains • fever
Uses 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 Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 8 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 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.
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 8 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 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.
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.
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 trouble urinating due to enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, or emphysema
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 enlarged prostate gland
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
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 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.
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.
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.
过量 / Overdosage
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 • do not exceed 8 softgels per 24 hrs adults & children 12 yrs & over 2 softgels with water every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use
Directions • take only as directed • do not exceed 8 softgels per 24 hrs adults & children 12 yrs & over 2 softgels with water every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use
dosage and administration table
<table width="100%"><tbody><tr><td>adults & children 12 yrs & over</td><td>2 softgels with water every 4 hrs</td></tr><tr><td>children 4 to under 12 yrs</td><td>ask a doctor</td></tr><tr><td>children under 4 yrs</td><td>do not use</td></tr></tbody></table>
<table border="0" width="100%"><tbody><tr><td>adults & children 12 yrs & over</td><td>2 softgels with water every 4 hrs</td></tr><tr><td>children 4 to under 12 yrs</td><td>ask a doctor</td></tr><tr><td>children under 4 yrs</td><td>do not use</td></tr></tbody></table>
储存 / Storage and handling
Other information store at no greater than 25°C
Other information store at no greater than 25°C
辅料 / Inactive ingredients
Inactive ingredients FD&C yellow no. 6 Al. lake, gelatin, glycerin, mica, polyethylene glycol 400, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide
Inactive ingredients D&C yellow no. 10 Al. lake, FD&C blue no. 1 Al. lake, gelatin, glycerin, mica, polyethylene glycol 400, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide
questions
Questions or comments? Call 1-800-910-6874
Questions or comments? Call 1-800-910-6874
package label principal display panel
PRINCIPAL DISPLAY PANEL daynight-ultra-96-ifc ny-part-label dy-part-label
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 3 / 20240822
- 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.

