STOMACH RELIEF REGULAR STRENGTH- bismuth subsalicylate liquid

Stomach Relief by

Drug Labeling and Warnings

Stomach Relief by is a Otc medication manufactured, distributed, or labeled by ATLANTIC BIOLOGICALS CORP., UNIT DOSE SOLUTIONS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 30 mL dose)

Bismuth subsalicylate 525 mg

Purpose

Upset stomach reliever/Antidiarrheal

Uses

relieves

• travelers' diarrhea
• diarrhea
• upset stomach due to overindulgence in food and drink, including:
  • heartburn
  • indigestion
  • nausea
  • gas
  • fullness
  • 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

• diabetes
• gout
• arthritis
• anticoagulation (thinning the blood)

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 childen.

In case of overdose, get medical help or contact a Posion Control Center (1-800-222-1222) right away.

Directions

• mL = milliliter
• shake well before using
• measure only with dosing cup provided. Do not use any other dosing device.
• keep dosing cup with product
• adults and children 12 years and over
  • 30 mL (1 dose) every 1/2 or 60 mL (2 doses) every hour as needed for diarrhea/traveler's diarrhea
  • 30 mL (1 dose) every 1/2 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 of age: ask a doctor
• drink plenty of clear fluids to help prevent dehydration caused by diarrhea

Other information

• each 30 mL contains: potassium 8 mg sodium 9 mg
• each 30 mL contains: salicylate 206 mg
• low sodium
• keep tightly closed
• protect from freezing
• avoid excessive heat (over 104ºF or 40ºC)

Inactive ingredients

benzoic acid, D&C red #22, D&C red #28, flavor, glycerin, purified water, sucralose, xanthan gum

Questions or comments?

Call 1-800-645-2158

Distributed by:

ATLANTIC BIOLOGICALS CORP.

20101 N.E 16th PLACE

MIAMI, FL 33179

Principal Display Panel

Compare to the active ingredient in Pepto-Bismol®*

Regular Strength

Stomach Relief

Bismuth Subsalicylate

Upset Stomach Reliever/Antidiarrheal

Relieves:

Heartburn Indigestion Nausea

Alcohol Free Sugar Free

INGREDIENTS AND APPEARANCE

STOMACH RELIEF  REGULAR STRENGTH
bismuth subsalicylate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17856-1286(NDC:0536-1286)
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
BENZOIC ACID (UNII: 8SKN0B0MIM)
D&C RED NO. 22 (UNII: 1678RKX8RT)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17856-1286-1	50 in 1 BOX, UNIT-DOSE	04/18/2024
1	NDC: 17856-1286-3	15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2	NDC: 17856-1286-2	50 in 1 BOX, UNIT-DOSE	04/18/2024
2	NDC: 17856-1286-4	30 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M	03/29/2020

Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)

Registrant - ATLANTIC BIOLOGICALS CORP. (047437707)

Establishment
Name	Address	ID/FEI	Business Operations
UNIT DOSE SOLUTIONS		360804194	repack(17856-1286)