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spl product data elements
Pepto-Bismol Bismuth subsalicylate D&C RED NO. 27 ALUMINUM LAKE CALCIUM CARBONATE MAGNESIUM STEARATE MANNITOL CELLULOSE, MICROCRYSTALLINE POLYSORBATE 80 SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO BISMUTH SUBSALICYLATE SALICYLIC ACID Caplet PeptoBismol
spl unclassified section
Drug Facts
TAMPER EVIDENT: Do not use if inner printed seal on bottle is broken or missing.
Relabeled by: Enovachem PHARMACEUTICALS Torrance, CA 90501
活性成分 / Active ingredient
Active ingredient (in each caplet) Bismuth subsalicylate 262 mg
用途 / Purpose
Purpose Upset stomach reliever and 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 belching fullness
警告 / Warnings
Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should 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 anticoagulation (thinning the blood) diabetes gout arthritis 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 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 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 anticoagulation (thinning the blood) diabetes gout arthritis
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 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 • swallow with water, do not chew • adults and children 12 years and over: 2 caplets (1 dose) every ½ hour or 4 caplets (2 doses) every hour as needed for diarrhea 2 caplets (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) • do not exceed 8 doses (16 caplets) in 24 hours • use until diarrhea stops but not more than 2 days • children under 12 years: ask a doctor • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
储存 / Storage and handling
Other information each caplet contains: calcium 27 mg salicylate 99 mg low sodium avoid excessive heat (over 104°F or 40°C)
辅料 / Inactive ingredients
Inactive ingredients calcium carbonate, D&C red No. 27 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, povidone, silicon dioxide, sodium starch glycolate
questions
Questions? 1-800-717-3786
package label principal display panel
PRINCIPAL DISPLAY PANEL 1
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 1 / 20251015
- 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.

