说明与适用边界
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spl product data elements
Ultra Bismuth Bismuth subsalicylate BISMUTH SUBSALICYLATE BISMUTH CATION SALICYLIC ACID BENZOIC ACID D&C RED NO. 22 D&C RED NO. 28 GLYCERIN WATER SUCRALOSE XANTHAN GUM
活性成分 / Active ingredient
Active ingredient (in each 15 mL dose) Bismuth subsalicylate 525 mg
用途 / Purpose
Purpose Upset stomach reliever/Antidiarrheal
适应证 / Indications and usage
Uses relieves travelers' diarrhea diarrhea upset stomach due to overindulgence in food and drink, including: heartburn indigestion nausea gas fullness belching
警告 / Warnings
Warnings Reye's syndrome : Children and teenagers who have or are recovering from chicken pox or flu-like symptoms ahould not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert: Contains salicylate. Do not take if you are: allergic to salicylates (including aspirin) taking other salicylate products Do not use if you have an ulcer a bleeding problem bloody or black stool Ask a doctor before use if you have fever mucus in the stool Ask a doctor or pharmacist before use if you are taking any drug for diabetes gout arthritis anticoagulation (thinning the blood) When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur. Stop use and ask a doctor if symptoms get worse or last more than 2 days ringing in the ears or loss of hearing occurs diarrhea lasts more than 2 days If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of childen. In case of overdose, get medical help or contact a Posion Control Center (1-800-222-1222) right away.
禁用事项 / Do not use
Do not use if you have an ulcer a bleeding problem bloody or black stool
咨询医生 / Ask a doctor
Ask a doctor before use if you have fever mucus in the stool
咨询医药人员 / Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if you are taking any drug for diabetes gout arthritis anticoagulation (thinning the blood)
使用中 / When using
When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur.
停用事项 / Stop use
Stop use and ask a doctor if symptoms get worse or last more than 2 days ringing in the ears or loss of hearing occurs diarrhea lasts more than 2 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 childen. In case of overdose, get medical help or contact a Posion Control Center (1-800-222-1222) right away.
用法用量原文 / Dosage and administration
Directions do not take more than 8 doses (120 mL) in 24 hours use until diarrhea stops but not more than 2 days drink plenty of clear fluids to help prevent dehydration caused by diarrhea mL = milliliter shake well before using measure only with dosing cup provided. Do not use any other dosing device. keep dosing cup with product adults and children 12 years and over: 15 mL (1dose) every 1/2 hour or 30 mL (2 doses) every hour as needed for diarrhea/traveler's diarrhea 15 mL (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) children under 12 years of age: ask a doctor
储存 / Storage and handling
Other information each 15 mL contains : sodium 5 mg each 15 mL contains : salicylate 206 mg low sodium keep tightly closed protect from freezing avoid excessive heat (over 104ºF or 40ºC)
辅料 / Inactive ingredients
Inactive ingredients benzoic acid, D&C red #22, D&C red #28, flavor, glycerin, purified water, sucralose, xanthan gum
questions
Questions or comments? Call toll free 1-866-4-REXALL
package label principal display panel
Principal Display Panel ULTRA Bismuth Bismuth subsalicylate 525 mg per 15 mL Upset stomach reliever / Antidiarrheal Soothing relief for: Heartburn Upset stomach Nausea Indigestion Diarrhea 2x Strength per ounce † Alcohol free • Sugar free GLUTEN FREE FL OZ (mL) † vs. Original Pepto-Bismol ® TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING . DISTRIBUTED BY OLD EAST MAIN CO. 100 MISSION RIDGE GOODLETTSVILLE, TN 37072
Package Label Ultra Bismuth Subsalicylate 525 mg per 15 mL Upset stomach reliever / Antidiarrheal
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 5 / 20240830
- 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.

