RITE AID STOMACH RELIEF ORIGINAL FLAVOR- bismuth subsalicylate tablet, chewable

Rite Aid Stomach Relief by

Drug Labeling and Warnings

Rite Aid Stomach Relief by is a Otc medication manufactured, distributed, or labeled by RITE AID CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Bismuth subsalicylate 262 mg

Purpose

Upset stomach reliever and antidiarrheal

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 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 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 immediately at 1-800-222-1222

Directions

• ▪ chew completely or dissolve tablets in mouth. Do not swallow tablets whole.
• ▪ 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 over indulgence (upset stomach, heartburn, indigestion, nausea.
• ▪ do not exceed 8 doses (16 tablets) in 24 hours
• ▪ use until diarrhea stops but not more than 2 days
• ▪ children under 12 years: ask a doctor
• ▪ drink plenty clear fluids to help prevent dehydration caused by diarrhea.

Other information

• ▪ each tablet contains: salicylate 102 mg
• ▪ store at room temperature.
• ▪ avoid excessive heat

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF STRIP UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

Inactive ingredients

D&C Red No. 27 lake, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucralose.

Questions or comments?

1-866-467-2748

Principal Display

NDC# 11822-2430-0

Compare to the active ingredient in Pepto-Bismol® Chewables*

Stomach Relief

Chewable Tablets

Bismuth Subsalicylate

Upset Stomach Reliever / Antidiarrheal

5 Symptoms Digestive Relief:

• Heartburn
• Indigestion
• Nausea
• Upset Stomach
• Diarrhea

Original Flavor

30 Chewable Tablets

Distributed by:

IMPORTANT: Keep this carton for future labeling.

*This product is not manufactured or distributed by Procter & Gamble Inc., the distributor of Pepto-Bismol® Chewables.

INGREDIENTS AND APPEARANCE

RITE AID STOMACH RELIEF  ORIGINAL FLAVOR
bismuth subsalicylate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-2430
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
D&C RED NO. 27 (UNII: 2LRS185U6K)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND	Size	17mm
Flavor		Imprint Code	RP124
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-2430-0	5 in 1 CARTON	03/30/2020
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 final	part335	03/30/2020

Labeler - RITE AID CORPORATION (014578892)