Target Bismuth Subsalicylate Caplets 262mg

Target Bismuth Subsalicylate Caplets 262mg
SPL v2
SPL
SPL Set ID 07aa10e2-dd03-f32d-e063-6294a90aad0d
Route
ORAL
Published
Effective Date 2024-06-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bismuth Cation (262 mg)
Inactive Ingredients
Povidone K30 Mannitol Silicon Dioxide D&c Red No. 27 Aluminum Lake Sodium Starch Glycolate Type A Magnesium Stearate Calcium Carbonate Microcrystalline Cellulose

Identifiers & Packaging

Pill Appearance
Imprint: 127 Shape: capsule Color: pink Size: 16 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-15

Description

Bismuth subsalicylate 262 mg

Purpose

Upset stomach reliever and antidiarrheal


Medication Information

Purpose

Upset stomach reliever and antidiarrheal

Description

Bismuth subsalicylate 262 mg

Uses

relieves

  • travelers' diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:

-heartburn

-indigestion

-nausea

-gas

-belching

-fullness

Section 34088-5

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

Section 51945-4

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
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
Do Not Use
  • an ulcer
  • a bleeding problem
  • bloody or black stool
Other Information
  • each caplet contains: calcium 27 mg
  • salicylate 99 mg
  • low sodium
  • store at room temperature
Inactive Ingredients

calcium carbonate, D&C red #27 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, povidone K-30, silicon dioxide, sodium starch glycolate

Questions Or Comments?

Call 1-877-290-4008

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.

Active Ingredient (in Each Caplet)

Bismuth subsalicylate 262 mg

Ask A Doctor Before Use If You Have
  • fever
  • mucus in the stool
Ask A Doctor Or Pharmacist Before Use If You Are
  • anticoagulation (thinning the blood)
  • diabetes
  • gout
  • arthritis

Structured Label Content

Uses

relieves

  • travelers' diarrhea
  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:

-heartburn

-indigestion

-nausea

-gas

-belching

-fullness

Section 34088-5 (34088-5)

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

Section 51945-4 (51945-4)

Purpose

Upset stomach reliever and antidiarrheal

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
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
Do Not Use (Do not use)
  • an ulcer
  • a bleeding problem
  • bloody or black stool
Other Information (Other information)
  • each caplet contains: calcium 27 mg
  • salicylate 99 mg
  • low sodium
  • store at room temperature
Inactive Ingredients (Inactive ingredients)

calcium carbonate, D&C red #27 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, povidone K-30, silicon dioxide, sodium starch glycolate

Questions Or Comments? (Questions or comments?)

Call 1-877-290-4008

When Using This Product (When using this product)

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

Stop Use and Ask A Doctor If (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, (If pregnant or breast feeding,)

ask a health professional before use.

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Bismuth subsalicylate 262 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • fever
  • mucus in the stool
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • anticoagulation (thinning the blood)
  • diabetes
  • gout
  • arthritis

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)