STOMACH RELIEF- bismuth subsalicylate tablet 
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.

----------

Rite Aid 44-346-Delisted

Active ingredient (in each caplet)

Bismuth subsalicylate 262 mg 

Purpose

Upset stomach reliever/antidiarrheal 

Uses

relieves:

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

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)
  • gout
  • diabetes
  • 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 (1-800-222-1222) right away. 

Directions

  • swallow with water; do not chew
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • adults and children 12 years and over: 2 caplets every ½ to 1 hour as needed. Do not exceed 8 doses (16 caplets) in 24 hours.
  • use until diarrhea stops, but not more than 2 days
  • children under 12 years: ask a doctor

Other information

  • each caplet contains: calcium 20 mg, salicylate 103 mg
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • avoid excessive heat
  • see end flap for expiration date and lot number 

Inactive ingredients

calcium carbonate, corn starch, D&C red #27 aluminum lake, D&C red #30 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, stearic acid

Questions or comments?

1-800-426-9391

Principal Display Panel

RITE
AID®
PHARMACY

*Compare to the active ingredient in Pepto-Bismol®

stomach relief
bismuth subsalicylate 262 mg
upset stomach reliever • antidiarrheal

soothing relief of 5 symptoms:
upset stomach, diarrhea, indigestion,
nausea and heartburn

ACTUAL SIZE

40 CAPLETS

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

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

SATISFACTION
GUARANTEE

IF YOU'RE NOT SATISFIED,
WE'LL HAPPILY REFUND
YOUR MONEY.

*This product is not manufactured or distributed by
Procter & Gamble, owner of the registered
trademark Pepto-Bismol®.
50844                  REV1016B34610

Rite Aid 44-346

Rite Aid 44-346

STOMACH RELIEF 
bismuth subsalicylate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0346
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE262 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
MANNITOL (UNII: 3OWL53L36A)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
STARCH, CORN (UNII: O8232NY3SJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorPINKScoreno score
ShapeOVALSize16mm
FlavorImprint Code 44;346
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-0346-11 in 1 CARTON05/06/201109/10/2021
140 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33505/06/201109/10/2021
Labeler - Rite Aid Corporation (014578892)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(11822-0346)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(11822-0346)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(11822-0346)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(11822-0346)

Revised: 12/2019
Document Id: d64a2e3d-3676-44ae-9ce8-db69e02eac55
Set id: a1dec9e5-479a-4bb5-82cb-78e021344c40
Version: 7
Effective Time: 20191210
 
Rite Aid Corporation