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



Active Ingredient

Active ingredient (in each tablet)

Bismuth subsalicylate 262 mg



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 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

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



Active Ingredient (55106-9)

Active ingredient (in each tablet)

Bismuth subsalicylate 262 mg



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

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 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)