说明与适用边界
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spl product data elements
Acetaminophen Acetaminophen STEARIC ACID STARCH, CORN SODIUM STARCH GLYCOLATE TYPE A POTATO POVIDONE K30 ACETAMINOPHEN ACETAMINOPHEN POLYETHYLENE GLYCOL, UNSPECIFIED HYPROMELLOSES Caplet Shape White to Off-White G551
活性成分 / Active ingredient
Active Ingredient (in each caplet) Acetaminophen USP, 500mg
用途 / Purpose
Purpose Pain Reliever / Fever Reducer
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.
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 relieves fever
警告 / Warnings
Warnings Liver warning This product contains acetaminophen. Sever liver damage may occur if you take more than 4000mg 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 ad seek medical medical help right away
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
儿童安全 / Keep out of reach of children
Keep out of reach of children Keep out of reach of children
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 older Take 2 tablets every 6 hours while symptoms last Do not take more than 6 tablets 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 of age Ask a doctor
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 a sign of a serious condition
孕哺期 / Pregnancy or breastfeeding
If pregnant or breast-feeding Ask a health professional before use
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 children even if you do not notice symptoms.
spl unclassified section
Other Information Store at 20ºC - 25ºC (68ºF - 77ºF). See USP controlled room temperature Avoid high humidity See end panel for expiration date and lot number Tamper Evident. Do not use if imprinted safety seal under cap is broken or missing Important. Read the directions and warnings before use
Distributed By: Distributed By: Trifecta Pharmaceuticals USA® Ft. Lauderdale, FL. 33301 USA 1-888-296-9067 *This product is not manufactured or distributed by the Johnson & Johnson Corporation, owner of the registered trademark Tylenol® Made in the USA
辅料 / Inactive ingredients
Inactive Ingredients hydroxypropyl methyl cellulose, polyethylene glycol, povidone K-30, Pregelatinized starch, Sodium starch glycolate, Stearic Acid
questions
Questions or Comments? Call 1-888-296-9067
package label principal display panel
Package Label globe acetaminophen caplet CDER
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 1 / 20231107
- 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.

