说明与适用边界
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spl product data elements
CalmCo Sleep Aid Gummy Bite Diphenhydramine HCl CARRAGEENAN STARCH, CORN MALTITOL GLYCERYL MONO AND DIPALMITOSTEARATE NEOTAME SODIUM CHLORIDE POVIDONE K30 SUCRALOSE POLYETHYLENE GLYCOL 400 TRISODIUM CITRATE DIHYDRATE PROPYLENE GLYCOL SUCROSE CORN SYRUP HYDROXYPROPYL BETADEX ACACIA WATER FD&C RED NO. 40 DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE
spl unclassified section
Drug Facts
活性成分 / Active ingredient
Active ingredient and Purpose Active ingredient Purpose Diphenhydramine HCl 25 mg .................. Nighttime sleep aid
active ingredient table
<table border="0" width="100%"><tbody><tr><td><content styleCode="italics"><content styleCode="bold">Active ingredient</content></content></td><td><content styleCode="italics"><content styleCode="bold">Purpose</content></content></td></tr><tr><td>Diphenhydramine HCl 25 mg ..................</td><td>Nighttime sleep aid</td></tr></tbody></table>
用途 / Purpose
Active ingredient Purpose Diphenhydramine HCl 25 mg .................. Nighttime sleep aid
purpose table
<table border="0" width="100%"><tbody><tr><td><content styleCode="italics"><content styleCode="bold">Active ingredient</content></content></td><td><content styleCode="italics"><content styleCode="bold">Purpose</content></content></td></tr><tr><td>Diphenhydramine HCl 25 mg ..................</td><td>Nighttime sleep aid</td></tr></tbody></table>
警告 / Warnings
Warnings Do not use for children under 12 years of age with any other product containing diphenhydramine, even one used on skin 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 tranquilizers When using this product avoid alcoholic drinks Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a 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 (1-800-222-1222) right away.
禁用事项 / Do not use
Do not use for children under 12 years of age with any other product containing diphenhydramine, even one used on skin
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 tranquilizers
使用中 / When using
When using this product avoid alcoholic drinks
停用事项 / Stop use
Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a 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 (1-800-222-1222) right away.
适应证 / Indications and usage
Uses for the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep
其他安全资料 / Other safety information
Other Information each piece: contains : sodium 9 mg . low sodium Store in a cool dry place between 20-25°C (68-77°F). Child Resistant Container; do not use if printed seal under cap is broken or missing.
辅料 / Inactive ingredients
Inactive Ingredients FD&C Red# 40, flavors, geleol mono and diglycerides, glucose syrup, gum arabic, hydroxypropyl betadex, maltitol solution, neotame, polyethylene glycol 400, povidone K30, propylene glycol, purified water, seaweed extract (carrageenan), sodium chloride, starch, sucralose, sucrose, trisodium citrate dihydrate.
用法用量原文 / Dosage and administration
Directions take only 1 dose per day (24 hours) chew each piece thoroughly before swallowing Age (Yrs) Dose (per piece) adults and children 12 years and over 1 to 2 pieces (25 mg to 50 mg) children under 12 years do not use
dosage and administration table
<table border="0" width="100%"><tbody><tr><td><content styleCode="bold">Age (Yrs)</content></td><td><content styleCode="bold">Dose (per piece)</content></td></tr><tr><td><paragraph>adults and children 12 years and over</paragraph></td><td>1 to 2 pieces (25 mg to 50 mg)</td></tr><tr><td>children under 12 years</td><td>do not use</td></tr></tbody></table>
questions
Questions or Comments? Call 941-203-4590 or visit www.calmco.com
package label principal display panel
Principal Display Panel Sleep Aid PDP sleep aid peel back
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 2 / 20241207
- 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.

