说明与适用边界
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spl product data elements
Theraflu Flu Relief Max Strength Daytime Acetaminophen, Dextromethorphan HBr ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN ANHYDROUS CITRIC ACID CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED GLYCERIN HONEY POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SODIUM GLUCONATE SUCRALOSE XANTHAN GUM ZINC GLUCONATE Elderberry
活性成分 / Active ingredient
Active ingredients (in each 30 mL) Acetaminophen 1000 mg Dextromethorphan HBr 30 mg
用途 / Purpose
Purposes Pain reliever/Fever reducer Cough suppressant
适应证 / Indications and usage
Uses • temporarily relieves these symptoms due to a common cold or flu: • headache • minor aches and pains • cough due to minor throat and bronchial irritation • minor sore throat pain • 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 • 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 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. 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
咨询医药人员 / Ask a doctor or pharmacist
停用事项 / Stop use
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.
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 children under 12 years of age do not use
dosage and administration table
<table width="98.88%"><col width="56%"/><col width="43%"/><tbody><tr><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"><list listType="ordered"><item><caption> </caption>Age</item></list></td><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"><list listType="ordered"><item><caption> </caption>Dose</item></list></td></tr><tr><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><list listType="ordered"><item><caption> </caption>adults and children 12 years of age and over</item></list></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><list listType="ordered"><item><caption> </caption>30 mL</item></list></td></tr><tr><td align="center" styleCode="Rrule Botrule Lrule " valign="top"><list listType="ordered"><item><caption> </caption>children under 12 years of age</item></list></td><td align="center" styleCode="Rrule Botrule Lrule " valign="top"><list listType="ordered"><item><caption> </caption>do not use</item></list></td></tr></tbody></table>
spl unclassified section
Other information • each 30 mL contains : potassium 5 mg, sodium 34 mg • store at controlled room temperature 20-25°C (68-77°F).
辅料 / Inactive ingredients
Inactive ingredients anhydrous citric acid, carboxymethylcellulose sodium, glycerin, natural and artificial flavors, natural grade A honey, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, xanthan gum, zinc gluconate
questions
Questions or comments? 1-855-328-5259
其他安全资料 / Other safety information
Additional Information PEEL BACK HERE DO NOT TAKE MORE THAN 3 DOSES IN TOTAL IN ANY 24 HOUR PERIOD. USE AS DIRECTED DO NOT USE IF NECKBAND PRINTED WITH “SEALED FOR SAFETY” IS TORN OR MISSING. *Maximum Strength per 6 hour dose. PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org Pat. Info www.productpats.com
package label principal display panel
Principal Display Panel THERAFLU FLU RELIEF MAX STRENGTH* Acetaminophen Pain Reliever/Fever Reducer Dextromethorphan HBr Cough Suppressant DAYTIME FORMULA Powerful fever fighting formula that relieves: / Body ache / Headache / Sore throat pain / Cough Honey & Elderberry Flavor 8.3 FL OZ (245.5mL) Theraflu Flu Relief MS 8.3 oz
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 5 / 20260107
- 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.

