DZA Brands, LLC Stomach Relief Drug Facts

Healthy Accents Stomach Relief by

Drug Labeling and Warnings

Healthy Accents Stomach Relief by is a Otc medication manufactured, distributed, or labeled by DZA Brands LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HEALTHY ACCENTS STOMACH RELIEF- bismuth subsalicylate suspension 
DZA Brands LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DZA Brands, LLC Stomach Relief Drug Facts

Active ingredient (in each 30 mL)

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
  • 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

  • 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
  • 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 the dose cup provided
  • adults and children 12 years and over: 1 dose (30 mL) every 1/2 to 1 hour as needed
  • 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: magnesium 15 mg, potassium 5 mg and sodium 12 mg
  • salicylate 254 mg
  • low sodium
  • store at 20-25°C (68-77°F). Avoid excessive heat over 104°F (40°C).
  • protect from freezing
  • does not meet USP requirements for pH
  • for health information visit www.more-info.info

Inactive ingredients

D&C red #22, D&C red #28, magnesium aluminum silicate, methyl salicylate, methylcellulose, purified water, saccharin sodium, salicylic acid, sodium salicylate, sorbic acid, xanthan gum

Questions or comments?

1-866-322-2439

Principal Display Panel

Compare to Pepto-Bismol® active ingredient

stomach relief

bismuth subsalicylate 525mg per 30mL

upset stomach reliever – antidiarrheal

5 symptom digestive relief:

nausea – upset stomach

heartburn – indigestion

diarrhea

8 FL OZ (237 mL)

NO GLUTEN

healthy accents stomach relief
HEALTHY ACCENTS STOMACH RELIEF 
bismuth subsalicylate suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55316-084
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE, SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE525 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
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)  
XANTHAN GUM (UNII: TTV12P4NEE)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
Product Characteristics
ColorPINK (viscous) Score    
ShapeSize
FlavorWINTERGREENImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55316-084-34237 mL in 1 BOTTLE; Type 0: Not a Combination Product02/07/201702/07/2017
2NDC: 55316-084-43473 mL in 1 BOTTLE; Type 0: Not a Combination Product02/07/201702/07/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33502/07/201702/07/2017
Labeler - DZA Brands LLC (090322194)

Revised: 4/2020
Document Id: a9aebbab-7bd2-42dd-932b-6f5c8aebd8e0
Set id: d6ab3693-7534-4d3c-a1b9-909d71df0bde
Version: 2
Effective Time: 20200415
 
DZA Brands LLC