STOMACH RELIEF- bismuth subsalicylate tablet, chewable

Stomach Relief by

Drug Labeling and Warnings

Stomach Relief by is a Otc medication manufactured, distributed, or labeled by Harmon Store Inc., LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each chewable 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 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 product

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

• diarrhea lasts more than 2 days
• ringing in the ears or loss of hearing occurs
• symptoms get worse

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 crush tablets completely before swallowing; do not swallow tablets whole
  
• drink plenty of clear fluids to help prevent dehydration caused by diarrhea
• adults and children 12 years and over: 2 chewable tablets every 1/2 to 1 hour as needed. Do not exceed 16 chewable tablets in 24 hours.
• do not use for more than 2 days unless directed by a doctor
  
• 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

CORE VALUES™

Compare to active ingredient in Pepto-Bismol®†

Stomach Relief

Bismuth subsalicylate 262 mg
Chewable Tablets
Upset Stomach Reliever/
Antidiarrheal

Relieves:
Nausea
Heartburn
Indigestion
Upset Stomach
Diarrhea

Actual Size

Chew or crush tablets completely before swallowing.
Do not swallow tablets whole.

30 chewable tablets           cherry flavor

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

Distributed by: Liberty Procurement, Inc.,
650 Liberty Ave., Union, NJ 07083 U.S.A
Satisfaction Guaranteed Or Your Money Back
Visit us at www.facevalues.com

†This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Pepto-Bismol®.
50844    REV0119A31901

Core Values 44-319

INGREDIENTS AND APPEARANCE

STOMACH RELIEF 
bismuth subsalicylate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63940-319
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
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
Color	PINK	Score	no score
Shape	ROUND	Size	16mm
Flavor	CHERRY	Imprint Code	44;319
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63940-319-01	5 in 1 CARTON	07/16/1998
1		6 in 1 POUCH; 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	07/16/1998

Labeler - Harmon Store Inc. (804085293)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(63940-319)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(63940-319)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(63940-319)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(63940-319)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(63940-319)