说明与适用边界
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spl product data elements
Sleep Aid Doxylamine Succinate DOXYLAMINE SUCCINATE DOXYLAMINE DIBASIC CALCIUM PHOSPHATE DIHYDRATE FD&C BLUE NO. 1 ALUMINUM LAKE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SODIUM STARCH GLYCOLATE TYPE A POTATO 44;386
活性成分 / Active ingredient
Active ingredient (in each tablet) Doxylamine succinate 25 mg
用途 / Purpose
Purpose Nighttime sleep-aid
适应证 / Indications and usage
Use helps to reduce difficulty in falling asleep
警告 / Warnings
Warnings Do not use in children under 12 years of age with any other product containing doxylamine unless you have time for a full night’s sleep Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or any other sleep-aid tranquilizers any other antihistamines any other drugs When using this product avoid alcoholic beverages do not drive a motor vehicle or operate machinery take only at bedtime Stop use and ask a doctor if sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
禁用事项 / Do not use
Do not use in children under 12 years of age with any other product containing doxylamine unless you have time for a full night’s sleep
咨询医生 / Ask a doctor
Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland
咨询医药人员 / Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if you are taking sedatives or any other sleep-aid tranquilizers any other antihistamines any other drugs
使用中 / When using
When using this product avoid alcoholic beverages do not drive a motor vehicle or operate machinery take only at bedtime
停用事项 / Stop use
Stop use and ask a doctor if sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness.
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.
用法用量原文 / Dosage and administration
Directions adults and children 12 years of age and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor children under 12 years of age: do not use
储存 / Storage and handling
Other information TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at controlled room temperature 20°-25°C (68°-77°F) see end flap for expiration date and lot number
辅料 / Inactive ingredients
Inactive ingredients dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate
questions
Questions or comments? Call 1-855-423-2630 Mon-Fri 8 am to 6 pm CST
package label principal display panel
Principal display panel EQUAL INE® compare to Unisom® SleepTabs® active ingredient* NDC 41163-986-22 nighttime sleep aid doxylamine succinate tablets, 25 mg (nighttime sleep aid) • just one tablet per dose 48 mini tablets actual size TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING *This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom® SleepTabs®. 50844 REV0123D38622 DISTRIBUTED BY UNFI PROVIDENCE, RI 02908 USA 855-423-2630 100% Quality GUARANTEED Equaline 44-386 Equaline 44-386
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 9 / 20260406
- 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.

