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spl product data elements
ACETAMINOPHEN ACETAMINOPHEN HYPROMELLOSE 2910 (6 MPA.S) MAGNESIUM STEARATE POVIDONE K30 STARCH, CORN STEARIC ACID ACETAMINOPHEN ACETAMINOPHEN SODIUM STARCH GLYCOLATE TYPE A CORN HYDROXYETHYL CELLULOSE (140 CPS AT 5%) MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 400 G650 ACETAMINOPHEN ACETAMINOPHEN MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL 400 POVIDONE K30 STARCH, CORN SODIUM STARCH GLYCOLATE TYPE A CORN STEARIC ACID ACETAMINOPHEN ACETAMINOPHEN HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) HYPROMELLOSE 2910 (6 MPA.S) G650 ACETAMINOPHEN ACETAMINOPHEN MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL 400 POVIDONE K30 STARCH, CORN SODIUM STARCH GLYCOLATE TYPE A CORN STEARIC ACID ACETAMINOPHEN ACETAMINOPHEN HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) HYPROMELLOSE 2910 (6 MPA.S) G650
活性成分 / Active ingredient
ACTIVE INGREDIENT (IN EACH CAPLET) Acetaminophen USP, 650 mg
用途 / Purpose
PURPOSE Pain reliever/fever reducer
适应证 / Indications and usage
USES For Arthritis Pain label • 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 For Muscle Aches & Pain label • 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 everyday 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
禁用事项 / Do not use
Do not use • with any other drugs 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 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 For Arthritis Pain Label • 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 For Muscle Ache and Pain label • do not take more than directed (see overdose warning) adults and children 12 years of age 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 cellspacing="0" cellpadding="0" border="0"><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle"><content styleCode="bold"> adults</content></td><td styleCode="Rrule" valign="middle"> • 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 </td></tr><tr><td styleCode="Lrule Rrule" valign="middle"><content styleCode="bold"> under 18 years of age </content></td><td styleCode="Rrule" valign="middle"> • ask a doctor</td></tr></tbody></table>
<table cellspacing="0" cellpadding="0" border="0"><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule" valign="middle"><content styleCode="bold"> </content>adults and children 12 years of age and over </td><td styleCode="Rrule" valign="middle"> • 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 </td></tr><tr><td styleCode="Lrule Rrule" valign="middle"><content styleCode="bold"> </content>children under 12 years </td><td styleCode="Rrule" valign="middle"> • do not use</td></tr></tbody></table>
spl unclassified section
OTHER INFORMATION • store between 20-25°C (68-77°F) • do not use if foil inner seal is broken or missing.
辅料 / Inactive ingredients
INACTIVE INGREDIENTS hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid
questions
QUESTIONS OR COMMENTS ? Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.
package label principal display panel
PRINCIPAL DISPLAY PANEL 62207-183-97 62207-183-35 62207-183-34 62207-183-49 62207-183-51-cont-labl 62207-183-51-crtn-labl 62207-183-87 62207-188-49 62207-188-51-cont-labl 62207-188-51-crtn-labl apap-er-10s-label-midol apap-er-10s-carton-midol
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 11 / 20260615
- 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.

