727r Dollar General 55910-204 Bismuth Subsalicylate Tablets 262 Mg

727r Dollar General 55910-204 Bismuth Subsalicylate Tablets 262 Mg
SPL v3
SPL
SPL Set ID f2ec112f-213c-8a23-e053-2995a90a5f3f
Route
ORAL
Published
Effective Date 2023-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: 118 Shape: round Color: pink Size: 15 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-09-18

Description

Active ingredient (in each tablet) Bismuth subsalicylate 262 mg


Medication Information

Warnings and Precautions

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



Indications and Usage

Uses relieves

travelers' diarrhea

diarrhea

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

o heartburn

o indigestion

o nausea

o gas

o belching

o 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 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 1-877-290-4008

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



Section 60561-8

Other information

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

Structured Label Content

Indications and Usage (34067-9)

Uses relieves

travelers' diarrhea

diarrhea

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

o heartburn

o indigestion

o nausea

o gas

o belching

o 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

Warnings and Precautions (34071-1)

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



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 1-877-290-4008

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



Section 60561-8 (60561-8)

Other information

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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)