BISMUTH- bismuth subsalicylate tablet 
Safecor Health, LLC

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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Drug Facts

Active ingredient

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

Purpose

Antidiarrheal/Antacid

Uses

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 if you have

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

Ask a doctor before use if you have

  • fever
  • mucus in the stool

Ask a doctor or pharmacist before use if you are taking any drug for

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

Stop use and ask a doctor if

  • symptoms get worse
  • ringing in the ears or loss of hearing occurs
  • diarrhea lasts more than 2 days

When using this product

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

If pregnant or breast-feeding

ask a health professional before use.

Keep Out of Reach of Children

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

Directions

Other Information

Phenylketonurics: contains phenylalanine 1.1 mg per tablet
Calcium content per tablet: ·73 mg
• save carton for full directions and warnings
• store at room temperature 15°- 30°C (59°- 86°F)

Inactive Ingredients

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

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 01801

06/2022 PN5728

Package/Label Principal Display Panel

Bismuth Subsalicylate
262 mg
Chewable Tablet
Mfg: Allegiant Health
Exp:02/03/24
Lot22A0016
PKG BY: Safecor Health
Woburn, MA
4843312701

Safecor Label

BISMUTH 
bismuth subsalicylate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48433-127(NDC:69168-046)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE262 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorpinkScoreno score
ShapeROUNDSize17mm
FlavorPEPPERMINTImprint Code RH046
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:48433-127-10100 in 1 BOX, UNIT-DOSE08/01/2020
1NDC:48433-127-011 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33508/01/2020
Labeler - Safecor Health, LLC (828269675)
Establishment
NameAddressID/FEIBusiness Operations
Safecor Health, LLC828269675repack(48433-127)
Establishment
NameAddressID/FEIBusiness Operations
Allegiant Health079501930manufacture(48433-127)

Revised: 6/2022
Document Id: 2b96078c-0b5d-48a7-bbc3-19209568a118
Set id: ba4d807b-4c9b-48ba-a8ea-1f6358a825d7
Version: 2
Effective Time: 20220611
 
Safecor Health, LLC