Your browser does not support JavaScript! STOMACH RELIEF (BISMUTH SUBSALICYLATE) CAPSULE [WAL-MART STORES INC]
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STOMACH RELIEF (bismuth subsalicylate) capsule
[Wal-Mart Stores Inc]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Active ingredient (in each caplet)

Bismuth subsalicylate 262 mg 

Purpose

Upset stomach reliever/Antidiarrheal 

Uses

relieves:

  • traveler's 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 vomitin goccur, 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

  • fever
  • mucus in the stool 

Ask a doctor or pharmacist before use if you are

taking any drug for

  • anticoagulation (thinning of 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 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

  • 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 1/2 to 1 hour as needed.  Do not exceend 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, D&C red #27 aluminium lake, D&C red #30 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, povidone, silicia gel, sodium starch glycolate, stearic acid 

Questions or comments?

 1-800-426-9391

Principal display panel

equate®

NDC 49035-346-10

Compare to Pepto-Bismol® active ingredient*

Stomach Relief
Pink Bismuth subsalicylate 262 mg

5 Symptom Relief of:
• Nausea    • Heartburn    • Indigestion
• Diarrhea    • Upset Stomach

ACTUAL SIZE

24 Caplets

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

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

50844        ORG121034608

Equate 44-346

Equate 44-346

STOMACH RELIEF 
bismuth subsalicylate capsule
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:49035-346
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (SALICYLIC ACID) BISMUTH SUBSALICYLATE262 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 27 
D&C RED NO. 30 
CALCIUM CARBONATE 
MANNITOL 
Product Characteristics
ColorPINKScoreno score
ShapeCAPSULESize15mm
FlavorImprint Code 44;346
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49035-346-101 in 1 CARTON
140 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33505/06/2011
Labeler - Wal-Mart Stores Inc (051957769)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(49035-346)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(49035-346)

Revised: 4/2013
 
Wal-Mart Stores Inc

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