Bismuth Subsalicylate 262 mg

Bismuth Subsalicylate 262 mg by

Drug Labeling and Warnings

Bismuth Subsalicylate 262 mg by is a Otc medication manufactured, distributed, or labeled by Preferred Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BISMUTH SUBSALICYLATE 262 MG- bismuth subsalicylate tablet, chewable 
Preferred Pharmaceuticals Inc.

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Bismuth Subsalicylate 262 mg

Drug Facts

Active ingredient (in each tablet)

Bismuth subsalicylate 262 mg

Purposes

Anti-diarrheal / Upset stomach reliever

Uses

  • controls diarrhea
  • relieves upset stomach due to overindulgence in food or drink

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 salicylates. Do not take if you are:

  • allergic to salicylates (including aspirin)
  • taking other salicylate products

Do not use

  • if you have bloody or black stool
  • if you have an ulcer or bleeding problem

Drug Facts continued on back of label

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

When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur

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

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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • repeat dosage every 1/2 to 1 hour as needed
  • do not take more than 8 doses in 24 hours
  • use until diarrhea stops but not more than 2 days
  • adults and children 12 years and over: 2 tablets
  • children under 12 years: ask a doctor

Other information

  • each tablet contains: calcium 77 mg, salicylate 102 mg
  • store at 15°-30°C (59°-86°F)
  • protect from moisture

Inactive ingredients

calcium carbonate, D&C red #27 (Al-lake), dextrose, flavor (cherry), magnesium stearate, maltodextrin, silicon dioxide, sorbitol

Questions or comments?

call 516-341-0666, 8:30 am- 4:30 pm ET, Monday-Friday

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Pepto-Bismol®

Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580

Relabeled By: Preferred Pharmaceuticals Inc.

www.reliable1labs.com

NDC: 68788-8128-3

Bismuth Subsalicylate

262 mg

UPSET STOMACH RELIEVER / ANTIDIARRHEAL

30 CHEWABLE TABLETS

*compare to Active Ingredients in Pepto-Bismol®

Bismuth Subsalicylate Tablets 262mg
BISMUTH SUBSALICYLATE 262 MG 
bismuth subsalicylate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 68788-8128(NDC: 69618-029)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE, SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE262 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
CHERRY (UNII: BUC5I9595W)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorpinkScoreno score
ShapeROUNDSize16mm
FlavorCHERRYImprint Code AP;045
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 68788-8128-330 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/03/202201/15/2024
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug33502/03/202201/15/2024
Labeler - Preferred Pharmaceuticals Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals Inc.791119022RELABEL(68788-8128)

Revised: 1/2024