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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 · ACETAMINOPHEN (RED)

ACETAMINOPHEN

ACETAMINOPHEN (RED) · Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.。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

此页按所列地区、版本归档。标签内容可能更新,具体产品请核对原始来源;本站关联表示阅读线索,不表示药品与器械可兼容或可替换。

spl product data elements

ACETAMINOPHEN (RED) ACETAMINOPHEN FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE PROPYLENE GLYCOL WATER SORBITOL ACETAMINOPHEN ACETAMINOPHEN clear oblong PC17

spl unclassified section

Drug Facts

活性成分 / Active ingredient

Active ingredient (in each capsule) Acetaminophen 325 mg

用途 / Purpose

Purpose Pain reliever/ fever reducer

适应证 / Indications and usage

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

警告 / Warnings

Warnings Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 softgels (3,250 mg) in 24 hours for adults or 5 softgels (1,625 mg) in 24 hours for children. Severe liver damage may occur if adult takes more than 4,000 mg of acetaminophen in 24 hours child takes more than 5 doses in 24 hours, which is the maximum daily amount taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks every day while using this product 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 the user has liver disease Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin Stop use and ask a doctor if pain gets worse or lasts more than 10 days in adults pain gets worse or lasts more than 5 days in children under 12 years 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 Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. 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 the user has liver disease

咨询医药人员 / Ask a doctor or pharmacist

Ask a doctor or pharmacist before use if the user is 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 in adults pain gets worse or lasts more than 5 days in children under 12 years 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.

过量 / Overdosage

Overdose warning Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. 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 softgels every 4 to 6 hours while symptoms last do not take more than 10 softgels in 24 hours do not use for more than 10 days unless directed by a doctor Children 6-11 years take 1 softgel every 4 to 6 hours while symptoms last do not take more than 5 softgels 24 hours do not use for more than 5 days unless directed by a doctorr children under 6 years ask a doctor

dosage and administration table

<table width="435" ID="id_d9660161-7d96-40b8-a55f-2d685e60bfc0" border="single"><col width="25.3%"/><col width="80.7%"/><tbody><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule"><paragraph>Adults and children 12 years and over</paragraph></td><td align="left" styleCode="Botrule Rrule"><list listType="unordered"><item>take 2 softgels every 4 to 6 hours while symptoms last</item><item>do not take more than 10 softgels in 24 hours</item><item>do not use for more than 10 days unless directed by a doctor</item></list></td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule"><paragraph>Children 6-11 years</paragraph></td><td align="left" styleCode="Botrule Rrule"><list listType="unordered"><item>take 1 softgel every 4 to 6 hours while symptoms last</item><item>do not take more than 5 softgels 24 hours</item><item>do not use for more than 5 days unless directed by a doctorr</item></list></td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule"><paragraph>children under 6 years</paragraph></td><td align="left" styleCode="Botrule Rrule"><list listType="unordered"><item>ask a doctor</item></list></td></tr></tbody></table>

储存 / Storage and handling

Other information store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat

辅料 / Inactive ingredients

Inactive ingredients FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special and white edible ink. Manufactured by: Humanwell PuraCap Pharmaceutical (Wuhan) Ltd. Wuhan, Hubei 430206, China

package label principal display panel

PRINCIPAL DISPLAY PANEL - Shipping Label ACETAMINOPHEN CAPSULES, 325 mg Quantity : 5000 Capsules NDC. No : 53345-010-01 IMPORTANT: Inspect immediate upon receipt. This is a bulk shipment intended for further processing only. Protect from heat, humidity, and light. Do not refrigerate. CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING" Shipping Label

来源、版本与许可

资料类型
美国药品标签原文
版本
3 / 20241125
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