STOMACH RELIEF- bismuth subsalicylate tablet, chewable

Stomach Relief by

Drug Labeling and Warnings

Stomach Relief by is a Otc medication manufactured, distributed, or labeled by SDA Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each tablet)

Bismuth subsalicylate 262mg

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 symtoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert: 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

Ask a doctor before use if you have

• fever
• mucus in the stool

Ask a doctor or pharmacist before use if you are

talking 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
• 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 untill 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 to 300C (59 to 860F)
• 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?

Adverse drug event call 1-(714)-903-7952

Principal Display Panel

NDC: 66424-045-30

Stomach Relief

Bismuth Subsalicylate 262 mg

Anti-Diarrheal/ Upset Stomach Reliever

Helps to Relieve:

• Upset Stomach
• Diarrhea
• Indigestion
• Heartburn
• Nausea

†Compare to the Active Ingredients in Pepto-Bismol

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

†This product is not manufactured or distributed by Proctor & Gamble, owner of the registered trademark Pepto-Bismol

INGREDIENTS AND APPEARANCE

STOMACH RELIEF 
bismuth subsalicylate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66424-045
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
D&C RED NO. 27 (UNII: 2LRS185U6K)
DEXTROSE (UNII: IY9XDZ35W2)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	pink (light)	Score	no score
Shape	ROUND	Size	16mm
Flavor	CHERRY	Imprint Code	AP;045
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66424-045-30	30 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part335	09/27/2012

Labeler - SDA Laboratories, Inc. (948067889)