STOMACH RELIEF REGULAR STRENGTH- bismuth subsalicylate suspension

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. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 30 mL dose )

Bismuth subsalicylate 525 mg

Purposes

Upset stomach reliever and antidiarrheal

Uses

relieves

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

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

• ▪ 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 right away (1-800-222-1222).

Directions

• ▪ shake well before use
• ▪ Only use dose cup provided
• ▪ adults and children 12 years and over: 30 mL (1 dose) every ½ hour or 60 mL (2 doses) every hour as needed for diarrhea/traveler’s diarrhea
• ▪ 30 mL (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
• ▪ do not exceed 8 doses (240 mL) 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 30 mL contains: potassium 14 mg, sodium 10 mg
• ▪ salicylate 260 mg
• ▪ low sodium
• ▪ sugar free
• ▪ store at room temperature
• ▪ protect from freezing
• ▪ avoid excessive heat (more than over 104°F or 40°C).

Inactive ingredients

carboxymethylcellulose sodium, D&C red #22, D&C red #28, flavor, gellan gum, microcrystalline cellulose, potassium hydroxide, potassium sorbate, purified water, salicylic acid, Simethicone emulsion, sodium benzoate, sucralose, xanthan gum

Questions or comments?

1-866-467-2748

Safety Sealed: DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN

Principal Display Panel

NDC: 70000-0698-1

COMPARE TO PEPTO-BISMOL® ORIGINAL LIQUID active ingredient*

LEADER™

Regular Strength

Stomach Relief

Bismuth Subsalicylate, 525 mg

Upset Stomach Reliever/Antidiarrheal

Original Flavor

Relieves:

• Nausea
• Heartburn
• Indigestion
• Upset Stomach
• Diarrhea

8 FL OZ (236 mL)

100% Money Back Guarantee

Dist. By CAH DUBLIN, OH 43017

www.myleader.com

1-800-200-6313

©2024 Cardinal Health.

*This product is not manufactured or distributed by Procter & Gamble, distributor of Pepto-Bismol® Original Liquid.

INGREDIENTS AND APPEARANCE

STOMACH RELIEF  REGULAR STRENGTH
bismuth subsalicylate suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0698
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE, SALICYLIC ACID - UNII:O414PZ4LPZ)	BISMUTH SUBSALICYLATE	525 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
D&C RED NO. 22 (UNII: 1678RKX8RT)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
SALICYLIC ACID (UNII: O414PZ4LPZ)
DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)
GELLAN GUM (HIGH ACYL) (UNII: W1L7G7ROMD)

Product Characteristics
Color	PINK (viscous)	Score
Shape		Size
Flavor	WINTERGREEN (ORIGINAL)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0698-1	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/21/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M008	10/21/2024

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