Gastrobiz Bismuth Subsalicylate 262mg

Gastrobiz Bismuth Subsalicylate 262mg

Drug Labeling and Warnings

Drug Details

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GASTROBIZ- bismuth subsalicylate tablet, chewable 
Allegiant Health

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Gastrobiz Bismuth Subsalicylate 262mg

Active ingredient

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

Purpose

Antidiarrheal/Antacid

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

Do not use

Do not use if you have

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

Ask a doctor before use if

Ask a doctor before use if you have

  • fever
  • mucus in the stool

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

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

Pregnancy/Breastfeeding

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

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.

Directions

  • chew or dissolve in mouth
  • Adults and children 12 years and over: 2 tablets every ½ to 1 hour as needed
  • do not exceed 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

Other information

  • Phenylketonurics: contains phenylalanine 1.1mg per tablet
  • Calcium content per tablet: 73mg
  • save carton for full directions and warnings
  • store at room temperature 15°– 30°C (59°– 86°F)
  • do not use if cellophane unit is torn

Inactive ingredients

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

Principal Display Panel

SUMMR®

Compare to Pepto Bismol® Active Ingredient

Gastrobiz

Bismuth Subsalicylate 262 mg

UPSET STOMACH RELIEVER/ANTI-DIARRHEAL

PROTECTIVE COATING ACTION

SUGAR FREE - LOW SODIUM

30 CHEWABLE TABLETS

PEPPERMINT FLAVOR

MADE IN U.S.A. (logo)Gastrobiz (Bismuth subsalicylate 262mg)

Gastrobiz (Bismuth subsalicylate 262mg)

GASTROBIZ 
bismuth subsalicylate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69168-999
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE262 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA (UNII: 5C5403N26O)  
ASPARTAME (UNII: Z0H242BBR1)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
DEXTRATES (UNII: G263MI44RU)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
PEPPERMINT (UNII: V95R5KMY2B)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize17mm
FlavorPEPPERMINTImprint Code RH;046
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69168-999-9830 in 1 CARTON07/04/2014
11 in 1 CELLO PACK; Type 0: Not a Combination Product
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33507/04/2014
Labeler - Allegiant Health (079501930)
Registrant - Allegiant Health (079501930)

Revised: 9/2018
 
Allegiant Health


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