Target Bismuth Subsalicylate Chewable Tablets 262 Mg

Target Bismuth Subsalicylate Chewable Tablets 262 Mg
SPL v2
SPL
SPL Set ID 07a932fb-38eb-4b35-e063-6394a90ad61f
Route
ORAL
Published
Effective Date 2024-05-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bismuth Cation (262 mg)
Inactive Ingredients
Saccharin Sodium D&c Red No. 27 Aluminum Lake Calcium Carbonate Talc Mannitol Magnesium Stearate Povidone, Unspecified

Identifiers & Packaging

Pill Appearance
Imprint: 118 Shape: round Color: pink Size: 15 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-15

Description

Active ingredient (in each tablet) Bismuth subsalicylate 262 mg


Medication Information

Indications and Usage

Uses relieves

-travelers' diarrhea

-diarrhea

-upset stomach due to overindulgence in food and drink, including:

  • heartburn
  • indigestion
  • nausea
  • gas
  • belching
  • fullness
Dosage and Administration

Directions

  • 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 not more than 2 days
  • children under 12 years: ask a doctor
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
Description

Active ingredient (in each tablet) Bismuth subsalicylate 262 mg

Section 44425-7

Other information

  • each tablet contains: calcium 140 mg
  • salicylate 101 mg
  • low sodium
  • avoid excessive heat (over 104°F or 40°C)
Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Section 50566-9

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
Section 50567-7

When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur

Section 50568-5

Ask a doctor or pharmacist before use if you are taking any drug for

  • anticoagulation (thinning the blood)
  • diabetes
  • gout
  • arthritis
Section 50569-3

Ask a doctor before use if you have

  • fever
  • mucus in the stool
Section 50570-1

Do not use if you have

  • an ulcer
  • a bleeding problem
  • bloody or black stool
Section 51727-6

Inactive ingredients calcium carbonate, D&C red #27 lake, flavor, magnesium stearate, mannitol, povidone, saccharin sodium, talc

Section 51945-4

Section 53413-1

Questions or comments? Call 1-800-910-6874

Section 53414-9

If pregnant or breast feeding, ask a health professional before use.

Section 55105-1

Purpose

Upset stomach reliever and antidiarrheal

Section 55106-9

Active ingredient (in each tablet)

Bismuth subsalicylate 262 mg

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

Structured Label Content

Indications and Usage (34067-9)

Uses 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)

Directions

  • 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 not more than 2 days
  • children under 12 years: ask a doctor
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
Section 44425-7 (44425-7)

Other information

  • each tablet contains: calcium 140 mg
  • salicylate 101 mg
  • low sodium
  • avoid excessive heat (over 104°F or 40°C)
Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Section 50566-9 (50566-9)

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
Section 50567-7 (50567-7)

When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking any drug for

  • anticoagulation (thinning the blood)
  • diabetes
  • gout
  • arthritis
Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • fever
  • mucus in the stool
Section 50570-1 (50570-1)

Do not use if you have

  • an ulcer
  • a bleeding problem
  • bloody or black stool
Section 51727-6 (51727-6)

Inactive ingredients calcium carbonate, D&C red #27 lake, flavor, magnesium stearate, mannitol, povidone, saccharin sodium, talc

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? Call 1-800-910-6874

Section 53414-9 (53414-9)

If pregnant or breast feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Upset stomach reliever and antidiarrheal

Section 55106-9 (55106-9)

Active ingredient (in each tablet)

Bismuth subsalicylate 262 mg

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

Advanced Ingredient Data


Raw Label Data

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