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spl product data elements
Theraflu Severe Cold relief Nighttime Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride ACESULFAME POTASSIUM ANHYDROUS CITRIC ACID ASPARTAME FD&C YELLOW NO. 6 MALTODEXTRIN SILICON DIOXIDE SODIUM CITRATE, UNSPECIFIED FORM LECITHIN, SOYBEAN SUCROSE TRIBASIC CALCIUM PHOSPHATE ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE white to off-white yellow, beige/brown granules Green Tea & Citrus
活性成分 / Active ingredient
Active ingredients (in each packet) Acetaminophen 500 mg Diphenhydramine HCl 25 mg Phenylephrine HCl 10 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 cold: minor aches and pains minor sore throat pain headache nasal and sinus congestion runny nose sneezing itchy nose or throat itchy, watery eyes due to hay fever cough due to minor throat and bronchial irritation 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. with any other product containing diphenhydramine, even one used on the skin 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 sedatives or tranquilizers taking the blood thinning drug warfarin 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 fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur pain, cough or nasal congestion gets worse or last more than 7 days 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. with any other product containing diphenhydramine, even one used on the skin 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 fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur pain, cough or nasal congestion gets worse or last more than 7 days 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 take every 4 hours, while symptoms persist. Do not take more than 6 packets in 24 hours unless directed by a doctor Age Dose adults and children 12 years of age and over one packet children under 12 years of age do not use dissolve contents of one packet into 8 oz. hot water; sip while hot. Consumer entire drink within 10-15 minutes. if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.
dosage and administration table
<table width="100%"><col width="72%"/><col width="28%"/><tbody><tr><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><list listType="ordered"><item>Age</item></list></td><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><list listType="ordered"><item>Dose</item></list></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><list listType="ordered"><item>adults and children 12 years of age and over</item></list></td><td styleCode="Rrule Lrule Botrule " valign="top"><list listType="ordered"><item>one packet</item></list></td></tr><tr><td styleCode="Rrule Botrule Lrule " valign="top"><list listType="ordered"><item>children under 12 years of age</item></list></td><td styleCode="Rrule Botrule Lrule " valign="top"><list listType="ordered"><item>do not use</item></list></td></tr></tbody></table>
其他安全资料 / Other safety information
Other information each packet contains : potassium 10 mg, sodium 23 mg phenylketonurics : contains phenylalanine 13 mg per packet store at controlled room temperature 20-25°C (68-77°F). Protect product from heat and moisture.
辅料 / Inactive ingredients
Inactive ingredients acesulfame potassium, anhydrous citric acid, aspartame, FD&C yellow no. 6, flavors, maltodextrin, silicon dioxide, sodium citrate, soy lecithin, sucrose, tribasic calcium phosphate
questions
Questions or Comments? call 1-800-328-5259
spl unclassified section
Generic Section TAMPER EVIDENT INNER UNIT DO NOT USE IF SEALED THERAFLU PACKET IS TORN OR BROKEN 1-855-328-5259 Distributed by: GSK Consumer Healthcare Warren, NJ 07059 ©2022 GSK group of companies or its licensor. Trademarks are owned by or licensed to the GSK group of companies. 62000000075407 HOT LIQUID THERAPY that relieves: Nasal and sinus congestion Cough Sore throat pain Headache Runny nose Fever PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.com *Temporarily controls cough to help you rest. This is not a sleep aid CARTON RECYCLE
package label principal display panel
Principal Display Panel NDC 0067-6801-02 MULTI-SYMPTOM COLD RELIEF THERAFLU SEVERE COLD RELIEF NIGHTTIME ACETAMINOPHEN PAIN RELIEVER/FEVER REDUCER DIPHENHYDRAMINE HCl ANTIHISTAMINE/COUGH SUPPRESSANT PHENYLEPHRINE HCl NASAL DECONGESTANT HELPS YOU REST* Hot liquid therapy that relieves: / Nasal and sinus congestion / Cough / Sore throat pain / Headache / Runny nose / Fever Citrus & Green Tea 6 PACKETS Theraflu Sever Cold Relief Citrus Green Tea 6 Packets
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 2 / 20240308
- 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.

