STOMACH RELIEF MULTI-SYMPTOM- bismuth subsalicylate tablet, chewable 
GREENBRIER INTERNATIONAL, INC.

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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Assured 44-319-Delisted

Active ingredient (in each tablet)

Bismuth subsalicylate 262 mg

Purpose

Upset stomach reliever/antidiarrheal

Uses

relieves:

  • diarrhea
  • traveler's 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 his 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 others 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 of 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, saccharin sodium, stearic acid, talc

Questions or comments?

1-800-426-9391

Principal display panel

Assured ™

COMPARE TO ACTIVE INGREDIENT OF PEPTO-BISMOL®*

MULTI-SYMPTOM

Stomach Relief

• Bismuth subsalicylate 262 mg

Upset Stomach Reliever
Anti-diarrheal

Cherry
Multi-Symptom Relief of
Nausea, Upset Stomach,
Heartburn, Diarrhea,
Indigestion

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
50844 ORG021531901

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

Item # 229932

DISTRIBUTED BY: GREENBRIER INTERNATIONAL INC.
500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

ASSURED 44-319

ASSURED 44-319

STOMACH RELIEF  MULTI-SYMPTOM
bismuth subsalicylate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-0319
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE262 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
POVIDONE (UNII: FZ989GH94E)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorPINK (dark) Scoreno score
ShapeROUNDSize16mm
FlavorCHERRYImprint Code 44;319
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33992-0319-15 in 1 CARTON07/16/199807/08/2019
16 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33507/16/199807/08/2019
Labeler - GREENBRIER INTERNATIONAL, INC. (610322518)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(33992-0319)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(33992-0319)

Revised: 8/2016
Document Id: ae21a785-75eb-4999-9dc1-d8a62456eeda
Set id: 373c79a5-35e9-44ab-b229-d0b41fa4b5fb
Version: 4
Effective Time: 20160815
 
GREENBRIER INTERNATIONAL, INC.