说明与适用边界
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spl product data elements
Extra Strength Pain Reliever mini softgels Acetaminophen 500 mg ACETAMINOPHEN ACETAMINOPHEN FD&C RED NO. 40 GELATIN GLYCERIN ISOPROPYL ALCOHOL N-BUTYL ALCOHOL POLYETHYLENE GLYCOL 400 POLYSORBATE 80 PROPYLENE GLYCOL WATER SHELLAC SORBITOL SOLUTION TITANIUM DIOXIDE SDP
spl unclassified section
Drug Fact
Distributed by: Shield Pharmaceuticals Corp. Ronkonkoma, NY 11779
活性成分 / Active ingredient
Active ingredients (in each softgel) Acetaminophen 500 mg
用途 / Purpose
Purpose Pain reliever/fever reducer
适应证 / Indications and usage
Uses temporarily relieves minor aches and pains due to: the common cold headache backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever
警告 / Warnings
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 4,000 mg of acetaminophen in 24 hours 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.
过量 / Overdosage
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 use more than directed (see overdose warning ) adults and children 12 years and over: take 2 softgels every 6 hours while symptoms last do not take more than 6 softgels in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children under 12 years: ask a doctor
dosage and administration table
<table width="100%"><tbody><tr><td>adults and children 12 years and over:</td><td><list listType="unordered"><item>take 2 softgels every 6 hours while symptoms last</item><item>do not take more than 6 softgels in 24 hours, unless directed by a doctor</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>ask a doctor</item></list></td></tr></tbody></table>
其他安全资料 / Other safety information
Other information store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
辅料 / Inactive ingredients
Inactive ingredients FD&C Red No. 40, gelatin, glycerin, isopropyl alcohol, N-butyl alcohol, polyethylene glycol, polysorbate 80, propylene glycol, purified water, shellac, sorbitol solution, titanium dioxide
questions
Questions or comments? 1-800-373-6981
package label principal display panel
Principal Display Extra Strength Pain Reliever mini softgels Acetaminophen 500 mg Pain reliever / Fever reducer Carton Label Pain Relief softgel Carton Pain Relief softgel Label
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 2 / 20260804
- 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.

