STOMACH RELIEF- bismuth subsalicylate tablet, chewable
Rite Aid Corporation

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.

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Rite Aid 44-319-Delisted

Active ingredient (in each tablet)

Bismuth subsalicylate 262 mg

Purpose

Upset stomach reliever/antidiarrheal

Uses

relieves:

diarrhea
travelers' diarrhea
upset stomach due to overindulgence in food and drink, including:
- indigestion
- nausea
- heartburn
- belching
- fullness
gas

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

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 (1-800-222-1222) right away.

Directions

chew or dissolve in mouth
drink plenty of clear fluids to help prevent dehydration caused by diarrhea
adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed. 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

Other information

each tablet contains: calcium 40 mg, salicylate 102 mg
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF CELLOPHANE UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
see end flap for expiration date and lot number
store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
avoid excessive heat
store in a dry place

Inactive ingredients

calcium carbonate, cherry flavor, D&C red #27 aluminum lake, D&C red #30 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate, mannitol, povidone, sodium saccharin, stearic acid, talc

Principal Display Panel

RITE
AID®
PHARMACY

*Compare to the active ingredient in Pepto-Bismol®

stomach
relief
bismuth subsalicylate 262 mg
upset stomach reliever/antidiarrheal

cherry flavor

relieves nausea,
heartburn, indigestion,
upset stomach
and diarrhea

ACTUAL SIZE

30 CHEWABLE TABLETS

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF CELLOPHANE UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

DISTRIBUTED BY:
RITE AID
30 HUNTER LANE, CAMP HILL, PA 17011

*This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Pepto-Bismol®.
50844 REV0215A31901
Rite Aid 44-319

Rite Aid 44-319

STOMACH RELIEF
bismuth subsalicylate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11822-0319
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
CALCIUM CARBONATE (UNII: H0G9379FGK)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 30 (UNII: 2S42T2808B)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
FD&C RED NO. 40 (UNII: WZB9127XOA)
POVIDONE (UNII: FZ989GH94E)

Product Characteristics
Color	pink	Score	no score
Shape	ROUND	Size	16mm
Flavor	CHERRY	Imprint Code	44;319
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11822-0319-0	5 in 1 CARTON	07/16/1998	08/27/2020
1		6 in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part335	07/16/1998	08/27/2020

Labeler - Rite Aid Corporation (014578892)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(11822-0319)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	manufacture(11822-0319)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	pack(11822-0319)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	pack(11822-0319)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(11822-0319)

Revised: 4/2020

Document Id: 67e1584b-9f5f-4062-964b-596dd8561eeb

Set id: 872f1f34-dffa-4888-b2f6-ad76c8a82294

Version: 8

Effective Time: 20200420

Rite Aid Corporation