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spl product data elements
NOTTS - Tension Headache Acetaminophen, Caffeine TALC D&C RED NO. 27 ALUMINUM LAKE SODIUM STARCH GLYCOLATE TYPE A STARCH, CORN MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SODIUM LAURYL SULFATE ACETAMINOPHEN ACETAMINOPHEN POVIDONE CAFFEINE CAFFEINE CROSCARMELLOSE SODIUM POLACRILIN POTASSIUM Notts;TH
spl unclassified section
Drug Facts
*This product is not manufactured or distributed by GSK group of companies, owner of the registered trademark Excedrin® Tension Headache Caplets. Distributed by: VIVUNT PHARMA LLC 8950 SW 74th Court, Suite 1901 Miami, FL 33156-3178 Made in India. www.vivunt.live
活性成分 / Active ingredient
Active ingredients (in each caplet) Purpose Acetaminophen 500 mg Pain Reliever Caffeine 65 mg Pain reliever Aid
active ingredient table
<table border="0" width="100%"><tbody><tr><td><content styleCode="italics">Active ingredients (in each caplet)</content></td><td><content styleCode="italics">Purpose</content></td></tr><tr><td>Acetaminophen 500 mg</td><td>Pain Reliever</td></tr><tr><td>Caffeine 65 mg</td><td>Pain reliever Aid</td></tr></tbody></table>
用途 / Purpose
Active ingredients (in each caplet) Purpose Acetaminophen 500 mg Pain Reliever Caffeine 65 mg Pain reliever Aid
purpose table
<table border="0" width="100%"><tbody><tr><td><content styleCode="italics">Active ingredients (in each caplet)</content></td><td><content styleCode="italics">Purpose</content></td></tr><tr><td>Acetaminophen 500 mg</td><td>Pain Reliever</td></tr><tr><td>Caffeine 65 mg</td><td>Pain reliever Aid</td></tr></tbody></table>
适应证 / Indications and usage
Uses For the temporary relief of minor aches and pains due to: common cold headache toothache muscular aches backaches premenstrual and menstrual cramps minor pain from arthritis
警告 / Warnings
Warnings Liver Warning: Liver warning: This product contains acetaminophen. Severe damage may occur if you take: more than 4,000 mg of acetaminophen in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day ehile using this product. Allergy alert: Acetaminophen may cause severe sking reactions. Symptoms may include: skin reddening rash blisters. If a skin reactions occurs, stop use and seek medical attention immediately Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness. and occasionally, rapid heartbeat. 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 allergic to acetaminophen or any of the inactive ingredients. Ask a doctor before use if you have liver disease. Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition If pregnant or breast-feeding, ask a healt professional before use. Keep out of the reach of children Overdose warning: Do not take more than recommended dosage. In case of overdose, get medical help or contact a Poison Control Center. 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 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 allergic to acetaminophen or any of the inactive ingredients.
咨询医生 / Ask a doctor
Ask a doctor before use if you have liver disease.
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 gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition
孕哺期 / Pregnancy or breastfeeding
If pregnant or breast-feeding, ask a healt professional before use.
儿童安全 / Keep out of reach of children
Keep out of the reach of children
用法用量原文 / Dosage and administration
Directions Do not use more than directed Do not take more than 6 caplets in 24 hours, or as directed by a doctor adults and children 12 years and over take 2 caplets every 6 hours children under 12 years ask a doctor
dosage and administration table
<table border="0" width="100%"><tbody><tr><td>adults and children 12 years and over</td><td><list listType="unordered"><item>take 2 caplets every 6 hours</item></list></td></tr><tr><td>children under 12 years</td><td><list listType="unordered"><item>ask a doctor</item></list></td></tr></tbody></table>
储存 / Storage and handling
Other information Store between 20-25 °C (68-77 °F) Tamper-evident: Do not use if carton is open or the foil inner seal is broken or missing.
辅料 / Inactive ingredients
Inactive ingredients Croscarmellose Sodium, D&C Red No.27 Aluminium Lake, Magnesium Stearate, Microcrystalline Cellulose, Polacrilin Potassium, Povidone, Sodium Lauryl Sulfate, Sodium Starch Glycolate, Starch, Talc.
package label principal display panel
Package Principal Display Panel - TH 24 Caplets NOTTS® Tension Headache 500 mg 65 mg each caplet Headaches Relief Aspirin Free Compare to Excedrin ® Tension Headache active ingredients* NDC 82706-010-01 24 CAPLETS TH 24
Package Principal Display Panel - TH 100 Caplets NOTTS® Tension Headache 500 mg 65 mg each caplet Headaches Relief Aspirin Free Compare to Excedrin® Tension Headache active ingredients* NDC 82706-010-02 100 CAPLETS TH 100
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 4 / 20231124
- 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.

