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 Healthy Accents (DZA Brands, LLC). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 30 mL )

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 ahould 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 right away. (1-800-222-1222)

Directions

• shake well before using
• mL = milliliter
• 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) or 2 TBSP)  1/2 to 1 hour as needed
  • do not exceed 8 doses (240 mL or 16 TBSP) 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 mLcontains: sodium 10 mg
• each 30 mL contains: salicylate 243 mg
• sugar free
• 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, magnesium aluminum silicate, methylcellulose, purified water, saccharin sodium, salicylic acid, sodium salicylate, sorbic acid

Questions or comments?

Call toll free 1-866-322-2439

Principal Display Panel

Compare to the active ingredient in Regular Strength Pepto-Bismol®*

Regular Strength

Stomach Relief

Bismuth subsalicylate 525 mg

upset stomach reliever/antidiarrheal

Soothing relief of:

Upset Stomach

• diarrhea
• indigestion
• nausea
• heartburn
• upset stomach

FL OZ (mL)

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

TAMPER EVIDENT; DO NOT USE IF PRINTED SAFETY SEAL UNDER AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY: DZA BRANDS, LLC

Salisbury, NC 28147/Scarborough, ME 04074

Package Label

Healthy Accents Regular Strength Stomach Relief

INGREDIENTS AND APPEARANCE

STOMACH RELIEF  REGULAR STRENGTH
bismuth subsalicylate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55316-372
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)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SALICYLIC ACID (UNII: O414PZ4LPZ)
SODIUM SALICYLATE (UNII: WIQ1H85SYP)
SORBIC ACID (UNII: X045WJ989B)
METHYLCELLULOSE (1500 CPS) (UNII: P0NTE48364)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55316-372-12	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/31/2015	12/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part335	03/31/2015	12/31/2020

Labeler - Healthy Accents (DZA Brands, LLC) (090322194)