Package/label Principal Display Panel

Package/label Principal Display Panel
SPL v4
SPL
SPL Set ID ba4d807b-4c9b-48ba-a8ea-1f6358a825d7
Route
ORAL
Published
Effective Date 2022-06-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Bismuth subsalicylate 262 mg (each tablet contains 102 mg salicylate)


Medication Information

Indications and Usage

relieves travelers’ diarrhea diarrhea   upset stomach due to overindulgence in food and drink including:   heartburn indigestion nausea gas belching fullness

Dosage and Administration

Chew or dissolve in mouth Adults and children 12 years and over : 2 tablets (1 dose) every ½ hour or 4 tablets (2 doses) every hour as needed for diarrhea 2 tablets (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) Do not exceed 8 doses (16 tablets) in 24 hours Use until diarrhea stops but no more than 2 days Children under 12 years of age: ask a doctor Drink plenty of clear fluids to help prevent dehydration caused by diarrhea

Description

Bismuth subsalicylate 262 mg (each tablet contains 102 mg salicylate)

Section 42229-5

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.

Section 50565-1

In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away. 

Section 50566-9

symptoms get worse ringing in the ears or loss of hearing occurs diarrhea lasts more than 2 days

Section 50567-7

a temporary, but harmless, darkening of the stool and/or tongue may occur

Section 50568-5

anticoagulation (thinning the blood) diabetes gout arthritis

Section 50569-3

fever mucus in the stool

Section 50570-1

an ulcer a bleeding problem bloody or black stool

Section 51727-6

acacia gum, aspartame, calcium carbonate, D & C red #27 aluminum lake, dextrates, magnesium stearate, maltodextrin, microcrystalline cellulose, peppermint flavor, silicon dioxide

Section 51945-4

Bismuth Subsalicylate 262 mg Chewable Tablet Mfg: Allegiant Health Exp:02/03/24 Lot22A0016 PKG BY: Safecor Health Woburn, MA 4843312701

Section 53414-9

ask a health professional before use.

Section 55105-1

Antidiarrheal/Antacid

Section 55106-9

Bismuth subsalicylate 262 mg (each tablet contains 102 mg salicylate)


Structured Label Content

Indications and Usage (34067-9)

relieves travelers’ diarrhea diarrhea   upset stomach due to overindulgence in food and drink including:   heartburn indigestion nausea gas belching fullness

Dosage and Administration (34068-7)

Chew or dissolve in mouth Adults and children 12 years and over : 2 tablets (1 dose) every ½ hour or 4 tablets (2 doses) every hour as needed for diarrhea 2 tablets (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) Do not exceed 8 doses (16 tablets) in 24 hours Use until diarrhea stops but no more than 2 days Children under 12 years of age: ask a doctor Drink plenty of clear fluids to help prevent dehydration caused by diarrhea

Section 42229-5 (42229-5)

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.

Section 50565-1 (50565-1)

In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away. 

Section 50566-9 (50566-9)

symptoms get worse ringing in the ears or loss of hearing occurs diarrhea lasts more than 2 days

Section 50567-7 (50567-7)

a temporary, but harmless, darkening of the stool and/or tongue may occur

Section 50568-5 (50568-5)

anticoagulation (thinning the blood) diabetes gout arthritis

Section 50569-3 (50569-3)

fever mucus in the stool

Section 50570-1 (50570-1)

an ulcer a bleeding problem bloody or black stool

Section 51727-6 (51727-6)

acacia gum, aspartame, calcium carbonate, D & C red #27 aluminum lake, dextrates, magnesium stearate, maltodextrin, microcrystalline cellulose, peppermint flavor, silicon dioxide

Section 51945-4 (51945-4)

Bismuth Subsalicylate 262 mg Chewable Tablet Mfg: Allegiant Health Exp:02/03/24 Lot22A0016 PKG BY: Safecor Health Woburn, MA 4843312701

Section 53414-9 (53414-9)

ask a health professional before use.

Section 55105-1 (55105-1)

Antidiarrheal/Antacid

Section 55106-9 (55106-9)

Bismuth subsalicylate 262 mg (each tablet contains 102 mg salicylate)


Raw Label Data

All Sections (JSON)