MAJOR BISMUTH SUBSALICYLATE- bismuth subsalicylate tablet, chewable

Major Bismuth Subsalicylate by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT(in each tablet)

Bismuth subsalicylate 262 mg

(total salicylate 102 mg per tablet)

PURPOSE

Upset stomach reliever and anti-diarrheal

USE(S)

relieves:

• diarrhea
• heartburn
• indigestion
• nausea
• upset stomach associated with these symptoms

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 behaviour 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

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

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 of 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 DOCTOR IF

• symptoms get worse
• 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 (1-800-222-1222) immediately.

DIRECTIONS

• chew or dissolve in mouth
• adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed
• do not take more than 8 doses (16 tablets) in 24 hours
• children under 12 years: ask a doctor
• drink plenty of clear fluids to help prevent dehydration caused diarrhea

OTHER INFORMATION

• each tablet contains:
• sodium less than 1 mg
• salicylate 102 mg
• very low sodium
• avoid excessive heat (over 104oF or 40oC)
• TAMPER EVIDENT: Do not use if individual compartments are torn on open. 

INACTIVE INGREDIENTS

calcium carbonate, D&C red 27 aluminum lake, flavor, magnesium stearate, mannitol, pregelatinized starch, saccharin sodium

PRINCIPAL DISPLAY PANEL

AJOR

NDC: 0904-7205-46
*Compare to the active ingredient in Pepto-Bismol®

Bismuth Subsalicylate 262 mg

Upset Stomach Reliever / Anti-diarrheal

Soothing, coating action provides fast relief for

heartburn, indigestion

nausea, upset stomach

and diarrhea

30 Chewable Tablets

INGREDIENTS AND APPEARANCE

MAJOR BISMUTH SUBSALICYLATE 
bismuth subsalicylate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-7205
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ)	BISMUTH SUBSALICYLATE	262 mg

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
D&C RED NO. 27 (UNII: 2LRS185U6K)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
STARCH, CORN (UNII: O8232NY3SJ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND	Size	16mm
Flavor		Imprint Code	G122
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-7205-46	5 in 1 BOX	10/11/2021
1		6 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 Drug	M008	10/11/2021

Labeler - Major Pharmaceuticals (191427277)