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西药 · 美国药品标签原文

对乙酰氨基酚 · 对乙酰氨基酚 · topcare 8 hr arthritis pain relief

ACETAMINOPHEN

topcare 8 hr arthritis pain relief · Topco Associates LLC。此记录对应特定产品,标签收录不代表所有用途获批。

说明与适用边界

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spl product data elements

topcare 8 hr arthritis pain relief Acetaminophen ACETAMINOPHEN ACETAMINOPHEN CARNAUBA WAX SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MALTODEXTRIN MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 POVIDONE, UNSPECIFIED STEARIC ACID TITANIUM DIOXIDE L544

活性成分 / Active ingredient

Active ingredient (in each caplet) Acetaminophen 650 mg

用途 / Purpose

Purpose Pain reliever/fever reducer

适应证 / Indications and usage

Uses • temporarily relieves minor aches and pains due to: • minor pain of arthritis • muscular aches • backache • premenstrual and menstrual cramps • the common cold • headache • toothache • temporarily reduces fever

警告 / Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 6 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 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. 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 in this product 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 • new symptoms occur • redness or swelling is present 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. Overdose warning: 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 • 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 in this product

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

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

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 • new symptoms occur • redness or swelling is present 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. Overdose warning: 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 take more than directed (see overdose warning) adults • take 2 caplets every 8 hours with water • swallow whole; do not crush, chew, split or dissolve • do not take more than 6 caplets in 24 hours • do not use for more than 10 days unless directed by a doctor under 18 years of age • ask a doctor

dosage and administration table

<table width="100%"><col width="25%"/><col width="75%"/><tbody><tr><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>adults</paragraph></td><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><list listType="unordered"><item><caption>&#x2022;</caption>take 2 caplets every 8 hours with water</item><item><caption>&#x2022;</caption>swallow whole; do not crush, chew, split or dissolve</item><item><caption>&#x2022;</caption>do not take more than 6 caplets in 24 hours</item><item><caption>&#x2022;</caption>do not use for more than 10 days unless directed by a doctor</item></list></td></tr><tr><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>under 18 years of age</paragraph></td><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><list listType="unordered"><item><caption>&#x2022;</caption>ask a doctor</item></list></td></tr></tbody></table>

储存 / Storage and handling

Other information • store at 20-25 ° C (68-77 ° F) • meets the requirements of USP Dissolution Test 2

辅料 / Inactive ingredients

Inactive ingredients carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, stearic acid, titanium dioxide

questions

Questions or comments? 1-888-423-0139

package label principal display panel

Principal Display Panel TopCare ® health COMPARE TO TYLENOL ® 8HR ARTHRITIS PAIN ACTIVE INGREDIENT 8 HR Arthritis Pain Relief ACETAMINOPHEN EXTENDED-RELEASE TABLETS, 650 mg PAIN RELIEVER • FEVER REDUCER DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN 8 HOUR For the Temporary Relief of Minor Arthritis Pain THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN actual size 150 CAPLETS† 650 mg EACH †CAPSULE-SHAPED TABLETS 8 hr arthritis pain relief image

来源、版本与许可

资料类型
美国药品标签原文
版本
3 / 20220523
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.
核对原始来源