CVS STOMACH RELIEF ULTRA STRENGTH- bismuth subsalicylate suspension

CVS Stomach Relief by

Drug Labeling and Warnings

CVS Stomach Relief by is a Otc medication manufactured, distributed, or labeled by CVS PHARMACY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 15 mL dose)

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 or 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 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 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 dose cup provided
• adults and children 12 years and over:
• 15 mL (1 dose) every ½ hour or 30 mL (2 doses) every hour as needed for diarrhea/traveler’s diarrhea
• 15 mL (1 dose) every ½ hour as needed overindulgence (upset stomach, heartburn, indigestion, nausea)
• do not exceed 8 doses (120 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 15 mL dose cup contains:potassium 7 mg, sodium 5 mg
• salicylate 230 mg
• low sodium
• sugar free
• store at room temperature
• protect from freezing
• avoid excessive heat (over 104°F or 40°C)

Inactive ingredients

carboxymethylcellulose sodium, D&C Red No. 22, D&C Red No. 28, flavor, microcrystalline cellulose, potassium hydroxide, potassium sorbate, purified water, salicylic acid, simethicone emulsion, sodium benzoate, sucralose, xanthan gum

Questions or comments?

1-866-467-2748

Do not use if imprinted shrink band is missing or broken.

Principal Display Panel

NDC: 51316-707-12

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

Ultra Strength

pink bismuth

bismuth subsalicylate

Upset Stomach Reliever/Antidiarrheal

Natural Cherry flavor

Relieves:

• Nausea
• Heartburn
• Indigestion
• Upset Stomach
• Diarrhea

12 FL. OZ. (354 mL)

2X CONCENTRATED FORMULA**

Distributed by:

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

INGREDIENTS AND APPEARANCE

CVS STOMACH RELIEF   ULTRA STRENGTH
bismuth subsalicylate suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51316-707
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 15 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
D&C RED NO. 22 (UNII: 1678RKX8RT)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
SALICYLIC ACID (UNII: O414PZ4LPZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-707-12	354 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/10/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M008	10/10/2022

Labeler - CVS PHARMACY (062312574)