Gastrobiz Bismuth Subsalicylate 262mg

Gastrobiz Bismuth Subsalicylate 262mg
SPL v9
SPL
SPL Set ID aa516512-afd7-453f-9c73-5fa930cafac3
Route
ORAL
Published
Effective Date 2018-09-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (262 mg)
Inactive Ingredients
Acacia Aspartame Calcium Carbonate D&c Red No. 27 Dextrates Magnesium Stearate Maltodextrin Microcrystalline Cellulose Peppermint Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: RH;046 Shape: round Color: pink Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-07-04

Description

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

Purpose

Antidiarrheal/Antacid


Medication Information

Purpose

Antidiarrheal/Antacid

Description

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

Uses

relieves 

  • travelers’ diarrhea
  • diarrhea

upset stomach due to overindulgence in food and drink including:

  • heartburn
  • indigestion
  • nausea
  • gas
  • belching
  • fullness
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
  • 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 1/2 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 of age: ask a doctor
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
Do Not Use

if you have

  • an ulcer
  • a bleeding problem
  • bloody or black stool
Active Ingredient

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

Other Information
  • Phenylketonurics: contains phenylalanine 1.1mg per tablet
  • Each tablet contains: calcium 73mg
  • save carton for full directions and warnings
  • store at room temperature 15°– 30°C (59°– 86°F)
  • avoid excessive heat (over 40°C or 104°F)
  • do not use if cellophane unit is torn
  • you may report side effects to 1888-952-0050
Inactive Ingredients

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

Pregnancy/breastfeeding

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

Principal Display Panel

SUMMR®

Compare to Pepto Bismol® Active Ingredient

Gastrobiz

Bismuth Subsalicylate 262 mg

UPSET STOMACH RELIEVER/ANTI-DIARRHEAL

PROTECTIVE COATING ACTION

LOW SODIUM

30 CHEWABLE TABLETS

PEPPERMINT FLAVOR

Gastrobiz
When Using This Product

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

Ask A Doctor Before Use If

you have

  • fever
  • mucus in the stool
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
Keep Out of Reach of Children

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

Ask A Doctor Or Pharmacist Before Use If

you are taking any drug for

  • anticoagulation (thinning of 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
Purpose

Antidiarrheal/Antacid

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
  • 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 1/2 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 of age: ask a doctor
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
Do Not Use (Do not use)

if you have

  • an ulcer
  • a bleeding problem
  • bloody or black stool
Active Ingredient (Active ingredient)

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

Other Information (Other information)
  • Phenylketonurics: contains phenylalanine 1.1mg per tablet
  • Each tablet contains: calcium 73mg
  • save carton for full directions and warnings
  • store at room temperature 15°– 30°C (59°– 86°F)
  • avoid excessive heat (over 40°C or 104°F)
  • do not use if cellophane unit is torn
  • you may report side effects to 1888-952-0050
Inactive Ingredients (Inactive ingredients)

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

Pregnancy/breastfeeding (Pregnancy/Breastfeeding)

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

Principal Display Panel

SUMMR®

Compare to Pepto Bismol® Active Ingredient

Gastrobiz

Bismuth Subsalicylate 262 mg

UPSET STOMACH RELIEVER/ANTI-DIARRHEAL

PROTECTIVE COATING ACTION

LOW SODIUM

30 CHEWABLE TABLETS

PEPPERMINT FLAVOR

Gastrobiz
When Using This Product (When using this product)

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

Ask A Doctor Before Use If (Ask a doctor before use if)

you have

  • fever
  • mucus in the stool
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
Keep Out of Reach of Children (Keep out of reach of children)

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

Ask A Doctor Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)

you are taking any drug for

  • anticoagulation (thinning of the blood)   
  • diabetes
  • gout
  • arthritis

Advanced Ingredient Data


Raw Label Data

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