说明与适用边界
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spl product data elements
8 Hour Pain Relief Acetaminophen POVIDONE K30 MICROCRYSTALLINE CELLULOSE HYPROMELLOSE, UNSPECIFIED TITANIUM DIOXIDE TRIACETIN ACETAMINOPHEN ACETAMINOPHEN STARCH, CORN SODIUM STARCH GLYCOLATE TYPE A HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) MAGNESIUM STEARATE CARNAUBA WAX White to off white 71 Capsule-shaped tablet
spl unclassified section
Drug Facts
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: muscular aches backache minor pain of arthritis toothache premenstrual and menstrual cramps headache the common cold 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
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 and children 12 years and over 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 children under 12 years do not use
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 8 hours with water</item><item>swallow whole; do not crush, chew, split, or dissolve</item><item>do not take more than 6 caplets in 24 hours</item><item>do not use for more than 10 days unless directed by a doctor</item></list></td></tr><tr><td>children under 12 years</td><td><list listType="unordered"><item>do not use</item></list></td></tr></tbody></table>
储存 / Storage and handling
Other information store between 20-25ºC (68-77ºF) The FDA approved dissolution methods differ from USP
辅料 / Inactive ingredients
Inactive ingredients carnauba wax, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin
questions
Questions or comments? Call 1-800-632-6900
package label principal display panel
apap-mp-100-label apap-mp-100-ifc
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 2 / 20240415
- 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.

