说明与适用边界
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spl product data elements
Midol Complete Gelcaps Midol Complete D&C RED NO. 33 ALUMINUM OXIDE EDETATE DISODIUM CAFFEINE CAFFEINE PYRILAMINE MALEATE PYRILAMINE FERROSOFERRIC OXIDE ACETAMINOPHEN ACETAMINOPHEN CARNAUBA WAX CROSCARMELLOSE SODIUM FD&C BLUE NO. 1 GELATIN GLYCERIN MIDOL
spl unclassified section
Drug Facts
活性成分 / Active ingredient
Active ingredients (in each gelcap) Purpose Acetaminophen 500 mg..............................………………….Pain reliever Caffeine 60 mg……….…………………………………….……..….Diuretic Pyrilamine maleate 15 mg……………………………………Antihistamine
用途 / Purpose
Purpose
适应证 / Indications and usage
Uses for the temporary relief of these symptoms associated with menstrual periods: cramps bloating water-weight gain headache backache muscle ache fatigue
警告 / Warnings
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take · more than 6 gelcaps in 24 hours, which is the maximum daily amount for this product · with other drugs containing acetaminophen · 3 or more alcoholic drinks every day while using this product Allergy Alert: acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include: · skin reddening · blisters · rash · hives · facial swelling · asthma (wheezing) · shock If a skin or general allergic reaction occurs, stop use and seek medical help right away.
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 have ever had an allergic reaction to this product or any of its ingredients
咨询医生 / Ask a doctor
Ask a doctor before use if you have · liver disease · glaucoma · difficulty in urination due to enlargement of the prostate gland · a breathing problem such as emphysema or chronic bronchitis
咨询医药人员 / Ask a doctor or pharmacist
使用中 / When using
When using this product · you may get drowsy · avoid alcoholic drinks · excitability may occur, especially in children · alcohol, sedatives, and tranquilizers may increase drowsiness · be careful when driving a motor vehicle or operating machinery · limit the use of caffeine-containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee.
停用事项 / Stop use
Stop use and ask a doctor if · new symptoms occur · redness or swelling is present · pain gets worse or lasts more than 10 days · fever gets worse or lasts more than 3 days
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. 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 the recommended dose · adults and children 12 years and older: · take 2 gelcaps with water · repeat every 6 hours, as needed · do not exceed 6 gelcaps per day · children under 12 years: consult a doctor
其他安全资料 / Other safety information
Other information · store at room temperature · avoid excessive heat 104°F (40°C)
辅料 / Inactive ingredients
Inactive ingredients black iron oxide, carnauba wax, croscarmellose sodium, D&C red #33 aluminum lake, edetate disodium, FD&C blue #1 aluminum lake, gelatin, glycerin, hypromellose, lecithin, magnesium stearate, microcrystalline cellulose, pregelatinized starch, propylene glycol, shellac, simethicone, stearic acid, titanium dioxide, triacetin
questions
Questions or comments? 1-800-331-4536 (Mon-Fri 9AM - 5PM EST)
package label principal display panel
Midol Complete Gelcaps 24ct Carton
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 6 / 20251204
- 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.

