HEALTHY ACCENTS STOMACH RELIEF ORIGINAL STRENGTH- bismuth subsalicylate liquid 
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 15 mL Tablespoon)

Bismuth subsalicylate 262 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
•
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
•
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
•
for accurate dosing, use dose cup
•
adults and children 12 years and over: 1 dose (2 Tbsp or 30 mL) every 1/2 to 1 hour as needed
•
do not exceed 8 doses (16 Tbsp or 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 Tbsp contains: magnesium 5 mg, potassium 5 mg and sodium 6 mg
•
salicylate 127 mg
•
sugar free
•
low sodium
•
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 262mg

upset stomach reliever - antidiarrheal

protective coating action

gluten free

soothing relief for 5 symptoms:

nausea

upset stomach

heartburn

indigestion

diarrhea

8 FL OZ (237 mL)

DZA Brands, LLC Stomach Relief
HEALTHY ACCENTS STOMACH RELIEF  ORIGINAL STRENGTH
bismuth subsalicylate liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55316-302
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (BISMUTH CATION and SALICYLIC ACID) BISMUTH SUBSALICYLATE262 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 22 
D&C RED NO. 28 
MAGNESIUM ALUMINUM SILICATE 
WATER 
SACCHARIN SODIUM 
SALICYLIC ACID 
SODIUM SALICYLATE 
SORBIC ACID 
XANTHAN GUM 
METHYL SALICYLATE 
Product Characteristics
ColorPINK (viscous) Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55316-302-43473 mL in 1 BOTTLE
2NDC:55316-302-34237 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33501/22/2008
Labeler - DZA Brands LLC (090322194)

Revised: 12/2013
Document Id: 008ad8dd-3daa-4cdd-9ee0-148bc4224382
Set id: cd7edd4e-a16b-4adc-b166-a10000ba88b4
Version: 2
Effective Time: 20131209
 
DZA Brands LLC