LEADER STOMACH RELIEF ORIGINAL STRENGTH- bismuth subsalicylate tablet, chewable

Leader Stomach Relief by

Drug Labeling and Warnings

Leader Stomach Relief by is a Otc medication manufactured, distributed, or labeled by Cardinal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Bismuth subsalicylate 262 mg

Purpose

Antidiarrheal/upset stomach reliever

(total salicylate 102 mg per tablet)

Uses

relieves

• ▪ travelers’ diarrhea
• ▪ diarrhea
• ▪ upset stomach due to overindulgence in food and drink, including:
• ▪ heartburn
• ▪ indigestion
• ▪ nausea
• ▪ gas
• ▪ 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 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 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 right away.

Directions

• ▪ chew or dissolve tablets in mouth
• ▪ drink plenty of clear fluids to help prevent dehydration caused by diarrhea
• ▪ adults and children 12 years and older: 2 tablets every ½ to 1 hour, or 4 tablets every hour as needed
• ▪ do not exceed 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: salicylate 102 mg
• ▪ Do not use if individual blister compartments are torn or open
• ▪ Store at room temperature 59°-86°F

Inactive ingredients

flavor, magnesium stearate, microcrystalline cellulose, red #27 aluminum lake, sorbitol, sucralose

Questions?

1-800-719-9260

Principal Display Panel

LEADER

NDC: 37205-720-65

Compare to Pepto-Bismol® active ingredient*

Pink Bismuth

Chewable Tablets

Bismuth Subsalicylate 262 mg

Original Flavor

Provides Soothing Relief for:

• Indigestion
• Upset Stomach
• Nausea
• Diarrhea
• Heartburn

SATISFACTION GUARANTEED

30 CHEWABLE TABLETS

All Leader® Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund.

Distributed By: Cardinal Health

Dublin, Ohio 43017

www.myleader.com

CIN 2572691

*This product is not manufactured or distributed by Procter & Gamble Inc., the distributor of PEPTO-BISMOL®.

Stomach Relief Chewables Carton

INGREDIENTS AND APPEARANCE

LEADER STOMACH RELIEF  ORIGINAL STRENGTH
bismuth subsalicylate tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-720
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
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
D&C RED NO. 27 (UNII: 2LRS185U6K)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND	Size	17mm
Flavor		Imprint Code	L469
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-720-65	5 in 1 CARTON	08/20/2019
1		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 final	part335	08/20/2019

Labeler - Cardinal Health (097537435)