Big Lots, Inc Stomach Relief Drug Facts

sound body stomach relief by

Drug Labeling and Warnings

sound body stomach relief by is a Otc medication manufactured, distributed, or labeled by Big Lots Stores, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SOUND BODY STOMACH RELIEF- bismuth subsalicylate suspension 
Big Lots Stores, Inc.

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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Big Lots, Inc 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: 12 mg
• salicylate 251 mg
• low sodium
• store at 20-25°C (68-77°F). Avoid excessive heat (over 104°F 40°C).
• protect from freezing
• for health information visit www.more-info.info

Inactive ingredients

D&C red #22, D&C red #28, glycerin, hydroxyethyl cellulose, methyl salicylate, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, saccharin sodium, salicylic acid, simethicone, sodium salicylate, sorbic acid, xanthan gum

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the Active Ingredient in Pepto-Bismol®

Relieves: Upset Stomach Diarrhea Indigestion Nausea Heartburn

Stomach Relief

Bismuth Subsalicylate 525 mg per 30 mL

Upset Stomach Reliever

Antidiarrheal

16 FL OZ (1 pt) (473 mL)

SOUND BODY STOMACH RELIEF 
bismuth subsalicylate suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50594-007
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
D&C RED NO. 22 (UNII: 1678RKX8RT)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
GLYCERIN (UNII: PDC6A3C0OX)
METHYL SALICYLATE (UNII: LAV5U5022Y)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SALICYLIC ACID (UNII: O414PZ4LPZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM SALICYLATE (UNII: WIQ1H85SYP)
SORBIC ACID (UNII: X045WJ989B)
XANTHAN GUM (UNII: TTV12P4NEE)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50594-007-43	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/29/2015	11/30/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part335	05/29/2015	11/30/2019

Labeler - Big Lots Stores, Inc. (017885351)

Revised: 4/2020

Document Id: 2f4b1fc4-18ae-42e6-ba41-a4aeeb494f6c

34390-5

Set id: fef51942-55ed-4325-88eb-ba60b802a133

Version: 5

Effective Time: 20200414

 

Big Lots Stores, Inc.