OTC Medication Information: Bismuth

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.

Active ingredient

Bismuth subsalicylate 262 mg (each tablet contains 102 mg 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 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

  • 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

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, MA4843312701

Safecor Label
(click image for full-size original)
BISMUTH bismuth subsalicylate tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:48433-127(NDC:69168-046)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BISMUTH SUBSALICYLATE (BISMUTH CATION) BISMUTH SUBSALICYLATE 262 mg
Inactive Ingredients
Ingredient Name Strength
ASPARTAME
CALCIUM CARBONATE
D&C RED NO. 27
DEXTRATES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
ACACIA
MALTODEXTRIN
PEPPERMINT
Product Characteristics
Color pink Score no score
Shape ROUND Size 17mm
Flavor PEPPERMINT Imprint Code RH046
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:48433-127-10 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (48433-127-01)
1 NDC:48433-127-01 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (48433-127-10)
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 Operations
Safecor Health, LLC 828269675 repack (48433-127)
Establishment
Name Address ID/FEI Operations
Allegiant Health 079501930 manufacture (48433-127)

Revised: 06/2022 Safecor Health, LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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