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 CARDINAL HEALTH 110, LLC. DBA LEADER, Guardian Drug Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT(in each tablet)

Bismuth subsalicylate 262 mg

(total salicylate 102 mg per tablet)

PURPOSE

Upset stomach reliever and anti-diarrheal

USE(S)

relieves:

• diarrhea
• heartburn
• indigestion
• nausea
• upset stomach associated with these symptoms

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

• bloody or black stool
• an ulcer
• a bleeding problem

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 of 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
• 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 immediately (1-800-222-1222).

DIRECTIONS

• chew or dissolve in mouth
• adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed
• do not take more than 8 doses (16 tablets) in 24 hours
• use until diarrhea stops but not more than 2 days
• children under 12 years: ask a doctor
• drink plenty of clear fluids to help prevent dehydration caused by diarrhea

OTHER INFORMATION

• each tablet contains:
• sodium less than 1 mg
• salicylate 102 mg
• very low sodium
• avoid excessive heat (over 104oF or 40oC)
• TAMPER EVIDENT: Do not use if individual compartments are torn on open. 

INACTIVE INGREDIENTS

calcium carbonate, D&C red 27 aluminum lake, flavor, magnesium stearate, mannitol, pregelatinized starch, saccharin sodium

PRINCIPAL DISPLAY PANEL

LEADER

NDC: 70000-0591-1
Stomach Relief

Bismuth Subsalicylate, 262 mg
Upset Stomach Reliever / Anti-Diarrheal

COMPARE TO PEPTO-BISMOL® active ingredient*

5 Symptom Digestive Relief: 

Diarrhea

Heartburn

Indigestion

Nausea

Upset stomach

30 CHEWABLE TABLETS

LEADER

NDC: 70000-0591-2
Stomach Relief

Bismuth Subsalicylate, 262 mg
Upset Stomach Reliever / Anti-Diarrheal

COMPARE TO PEPTO-BISMOL® active ingredient*

5 Symptom Digestive Relief: 

Diarrhea

Heartburn

Indigestion

Nausea

Upset stomach

48 CHEWABLE TABLETS

INGREDIENTS AND APPEARANCE

STOMACH RELIEF 
bismuth subsalicylate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0591
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
D&C RED NO. 27 (UNII: 2LRS185U6K)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
STARCH, CORN (UNII: O8232NY3SJ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND	Size	16mm
Flavor		Imprint Code	G122
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0591-1	5 in 1 BOX	10/05/2021
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 70000-0591-2	8 in 1 BOX	10/05/2021
2		6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M008	10/05/2021

Labeler - CARDINAL HEALTH 110, LLC. DBA LEADER (063997360)

Establishment
Name	Address	ID/FEI	Business Operations
Guardian Drug Company		119210276	MANUFACTURE(70000-0591)