STOMACH RELIEF- bismuth subsalicylate tablet

Stomach relief by

Drug Labeling and Warnings

Stomach relief by is a Otc medication manufactured, distributed, or labeled by Strategic Sourcing Services LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each caplet)

Bismuth subsalicylate 262 mg

Purpose

Upset stomach reliever and anti-diarrheal

KEEP OUT OF REACH OF CHILDREN

Uses

relieves:

• indigestion
• nausea
• heartburn
• diarrhea
• 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 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

• 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 a 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 immediately.

Directions

• Swallow caplet(s) with water, do not chew
• adults and children 12 years and over: 2 caplets every 1/2 to 1 hour as needed
• do not take more than 8 doses (16 caplets) in 24 hours
• use until diarrhea stops but not more than 2 days
• children under 12 years: ask a doctor
• drink plenty of fluids to help prevent dehydration which may accompany diarrhea.

Other information

• each caplet contains: calcium 27 mg, salicylate 102 mg and sodium 2 mg
• very low sodium
• TAMPER EVIDENT: Do not use if printed seal under cap is torn or missing.
• store at room temperature, in a dry place

Inactive ingredients

calcium carbonate, colloidal silicon dioxide, D&C red 27 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, sodium starch glycolate.

Principal Display Panel

sunmark

COMPARE TO PEPTO-BISMOL® ACTIVE INGREDIENT

NDC # 49348-511-59

stomach relief

Soothing relief for upset stomach, indigestion, nausea, heartburn and diarrhea

ORIGINAL FORMULA

40 CAPLETS

INGREDIENTS AND APPEARANCE

STOMACH RELIEF 
bismuth subsalicylate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49348-511
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE)	BISMUTH SUBSALICYLATE	262 mg

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
D&C RED NO. 27 (UNII: 2LRS185U6K)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MANNITOL (UNII: 3OWL53L36A)

Product Characteristics
Color	pink	Score	no score
Shape	capsule	Size	16mm
Flavor		Imprint Code	G172
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49348-511-59	1 in 1 CARTON	09/27/2019
1		40 in 1 BOTTLE; 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	09/27/2019

Labeler - Strategic Sourcing Services LLC (116956644)