Label: BISMUTH- bismuth subsalicylate tablet
- NDC Code(s): 48433-127-01, 48433-127-10
- Packager: Safecor Health, LLC
- This is a repackaged label.
- Source NDC Code(s): 69168-046
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated June 11, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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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
Ask a doctor or pharmacist before use if you are taking any drug for
- anticoagulation (thinning the blood)
- diabetes
- gout
- arthritis
- Keep Out of Reach of Children
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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 no 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
- Inactive Ingredients
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BISMUTH SUBSALICYLATE
262 mg Chewable Tablet
Contains 100 Unit Dose Blisters NDC: 48433-127-01
3 48433 127 10 0
GTIN: 00348433127100
SN: 222202401
Exp: 2024-03-27
Lot: 22A0078
These unit dose packages meet USP specifications for light resistance.
The package design is not child resistant. For institutional use only.
Distributed by Safecor Health, LLC 317 New Boston St, Woburn MA 0180106/2022 PN5728
- Package/Label Principal Display Panel
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INGREDIENTS AND APPEARANCE
BISMUTH
bismuth subsalicylate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:48433-127(NDC:69168-046) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE 262 mg Inactive Ingredients Ingredient Name Strength ASPARTAME (UNII: Z0H242BBR1) CALCIUM CARBONATE (UNII: H0G9379FGK) D&C RED NO. 27 (UNII: 2LRS185U6K) DEXTRATES (UNII: G263MI44RU) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ACACIA (UNII: 5C5403N26O) MALTODEXTRIN (UNII: 7CVR7L4A2D) PEPPERMINT (UNII: V95R5KMY2B) Product Characteristics Color pink Score no score Shape ROUND Size 17mm Flavor PEPPERMINT Imprint Code RH046 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:48433-127-10 100 in 1 BOX, UNIT-DOSE 08/01/2020 1 NDC:48433-127-01 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part335 08/01/2020 Labeler - Safecor Health, LLC (828269675) Establishment Name Address ID/FEI Business Operations Safecor Health, LLC 828269675 repack(48433-127) Establishment Name Address ID/FEI Business Operations Allegiant Health 079501930 manufacture(48433-127)
