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spl product data elements
ValuMeds Extra Strength Headache Relief ACETAMINOPHEN, ASPIRIN, CAFFEINE SILICON DIOXIDE HYPROMELLOSE, UNSPECIFIED MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE WATER STEARIC ACID TALC ACETAMINOPHEN ACETAMINOPHEN ASPIRIN ACETYLSALICYLIC ACID CAFFEINE CAFFEINE S53
spl unclassified section
Drug Facts
Other information each caplet contains: magnesium 0.58 mg store at controlled room temperature 20º - 25º C (68º - 77º F) read all product information before using.
活性成分 / Active ingredient
Active ingredients (in each caplet) Acetaminophen 250 mg Aspirin 250 mg (NSAID)* Caffeine 65 mg *nonsteroidal anti-inflammatory drug Purpose Pain reliever Pain reliever Pain reliever aid
用途 / Purpose
Purpose Pain reliever Pain reliever Pain reliever aid
适应证 / Indications and usage
Uses temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches sinusitis toothache premenstrual & menstrual cramps
警告 / Warnings
Warnings Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness. 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. Allergy alert: Aspirin may cause a severe allergic reaction which may include: • hives • facial swelling • asthma (wheezing) • shock Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 8 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you • are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed 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 if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask doctor before use if you have liver disease stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have heart disease, liver cirrhosis or kidney disease you are taking a diuretic you have high blood pressure you have asthma Ask a doctor or pharmacist before use if you are any other drug containing an NSAID (prescription or non-prescription) a prescription drug for diabetes, gout or arthritis any other drug, or are under a doctor's care for any serious condition a blood thinning (anticoagulant) or steroid drug Stop use and ask doctor if an allergic reaction occurs. Seek medical help right away. you experience any of the following signs of stomach bleeding feel faint • vomit blood • have bloody or black stools have stomach pain that does not get better ringing in the ears or loss of hearing occurs painful area is red or swollen pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days any new symptoms appear These could be signs of a serious condition. If pregnant or breast-feeding ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children 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.
禁用事项 / Do not use
Do not use if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
咨询医生 / Ask a doctor
咨询医药人员 / Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if you are any other drug containing an NSAID (prescription or non-prescription) a prescription drug for diabetes, gout or arthritis any other drug, or are under a doctor's care for any serious condition a blood thinning (anticoagulant) or steroid drug
停用事项 / Stop use
Stop use and ask doctor if an allergic reaction occurs. Seek medical help right away. you experience any of the following signs of stomach bleeding feel faint • vomit blood • have bloody or black stools have stomach pain that does not get better ringing in the ears or loss of hearing occurs painful area is red or swollen pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days any new symptoms appear 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. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
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 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 do not use more than directed (see Overdose warning) drink a full glass of water with each dose adults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours children under 12 years: ask a doctor
辅料 / Inactive ingredients
Inactive ingredients colloidal silicon dioxide, hypermellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, purified water, stearic acid, talc
questions
Questions or comments? contact 1-908-242-6108 Mon-Fri 8:00 AM to 5:00 PM EST
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Package Labeling: Outer Label0.jpg
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 1 / 20250131
- 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.

