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spl product data elements
Theraflu-D Flu Relief Max Strength plus Nasal Decongestant Nighttime Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Pseudoephedrine HCl ALCOHOL ANHYDROUS CITRIC ACID CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED D&C RED NO. 33 FD&C RED NO. 40 GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SUCRALOSE ACETAMINOPHEN ACETAMINOPHEN CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE Clear
活性成分 / Active ingredient
Active ingredients (in each 30 mL) Acetaminophen 1000 mg Chlorpheniramine maleate 4 mg Dextromethorphan HBr 30 mg Pseudoephedrine HCl 60 mg
用途 / Purpose
Purposes Pain reliever/Fever reducer Antihistamine Cough suppressant Nasal decongestant
适应证 / Indications and usage
Uses temporarily relieves these symptoms due to a common cold or flu: headache minor aches and pains minor sore throat pain runny nose cough due to minor throat and bronchial irritation nasal and sinus congestion temporarily reduces fever
警告 / Warnings
Warnings 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: 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 in a child under 12 years of age if you are allergic to acetaminophen 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. Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis cough that occurs with too much phlegm (mucus) cough that lasts or is chronic 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 exceed recommended dosage avoid alcoholic drinks marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs pain, cough or nasal congestion 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 breast-feeding, 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 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 in a child under 12 years of age if you are allergic to acetaminophen 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 glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis cough that occurs with too much phlegm (mucus) cough that lasts or is chronic 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 exceed recommended dosage avoid alcoholic drinks marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children
停用事项 / Stop use
Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs pain, cough or nasal congestion 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.
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 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 do not use more than directed measure the dose correctly using the enclosed dosing cup adults and children 12 years of age and over: take every 6 hours in dosing cup provided, while symptoms persist do not take more than 3 doses (90 mL) in 24 hours unless directed by a doctor children under 12 years of age: do not use Age Dose adults and children 12 years of age and over 30 mL every 6 hours children under 12 years of age do not use
dosage and administration table
<table width="100%" styleCode="Noautorules"><col width="53%"/><col width="45%"/><tbody><tr><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"><list listType="unordered"><item>Age</item></list></td><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"><list listType="unordered"><item>Dose</item></list></td></tr><tr><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><list listType="unordered"><item>adults and children 12 years of age and over</item></list></td><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"><list listType="unordered"><item>30 mL every 6 hours</item></list></td></tr><tr><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"><list listType="unordered"><item>children under 12 years of age</item></list></td><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"><list listType="unordered"><item>do not use</item></list></td></tr></tbody></table>
spl unclassified section
Other information each 30 mL contains : sodium 26 mg store at 20-25°C (68-77°F). Do not refrigerate. Keep bottle tightly closed.
辅料 / Inactive ingredients
Inactive ingredients alcohol, anhydrous citric acid, carboxymethylcellulose sodium, D&C red no. 33, FD&C red no. 40, glycerin, natural and artificial flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose
questions
Questions or comments? 1-855-328-5259
其他安全资料 / Other safety information
Additional Information READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE. KEEP CARTON FOR REFERENCE. DO NOT DISCARD. PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org DO NOT USE IF TEAR BAND ON CAP IS BROKEN OR MISSING. Distributed by: Haleon Warren, NJ 07059 Made in Canada ©2024 Haleon group of companies or its licensor. Trademarks are owned by or licensed to the Haleon group of companies. Pat. Info www.productpats.com
package label principal display panel
Principal Display Panel MULTI-SYMPTOM RELIEF NEW HALEON THERAFLU-D FLU RELIEF MAX STRENGTH* + NASAL DECONGESTANT NIGHTTIME Acetaminophen Pain Reliever/Fever Reducer Chlorpheniramine Maleate Antihistamine Dextromethorphan HBr Cough Suppressant Pseudoephedrine HCI Nasal Decongestant Fast, Powerful Multi-Symptom relief of: / Fever / Nasal congestion / Sinus Pressure / Head & Body Ache / Sore Throat Pain / Cough / Runny Nose / Sneezing Cherry Flavor 8.0 FL OZ (237 mL) 62000000209276 Carton Front Theraflu-D Flu Relief MS Nasal Decon NT 8.0 fl oz
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 1 / 20240503
- 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.

