Active Ingredient
Bismuth subsalicylate 262mg (each tablet contains 102mg salicylate)
Gastrobiz Tablet, Chewable
FDA Label NDC 69168-999
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allegiant Health for the product Gastrobiz (NDC 69168-999). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antidiarrheal/Antacid
Uses
relieves
- travelers’ diarrhea
- diarrhea
- heartburn
- indigestion
- nausea
- gas
- belching
- fullness
upset stomach due to overindulgence in food and drink including:
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
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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 1)
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