STOMACH RELIEF MAXIMUM STRENGTH- bismuth subsalicylate liquid

STOMACH RELIEF MAXIMUM STRENGTH by

Drug Labeling and Warnings

STOMACH RELIEF MAXIMUM STRENGTH by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Inc., Aurohealth LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each 30 mL dose cup)

Bismuth subsalicylate 1050 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 (1-800-222-1222) right away.

Directions

• shake well before use
• mL=milliliter
• use dose cup or tablespoon (TBSP)
• adults and children 12 years and over: 1 dose (30 mL or 2 TBSP) every hour as needed
• do not exceed 4 doses (120 mL or 8 TBSP) 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 dose cup contains: magnesium 15 mg, sodium 7 mg
• salicylate 436 mg
• very low sodium
• protect from freezing
• avoid excessive heat (over 104°F or 40°C)
• store at 20-25°C (68-77°F)
• TAMPER EVIDENT: Do not use if printed seal under cap is missing or broken.
• does not meet USP requirements for pH

Inactive ingredients

Benzoic acid, D&C red No.22, D&C red No. 28, flavors, magnesium aluminum silicate, methylcellulose, purified water, saccharin sodium, salicylic acid, sodium salicylate, sorbic acid, sucralose, xanthan gum

Questions or comments?

1-855-274-4122

TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR BROKEN.

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

Distributed by:
CVS Pharmacy, Inc.
One CVS Drive,
Woonsocket, RI 02895
© 2016 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
V-33009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 12 FL OZ (354 mL) Bottle

CVS Health
Compare to the active ingredient in
Pepto-Bismol® Max Strength*
Cherry Flavor
NDC: 69842-005-40
MAXIMUM STRENGTH
Stomach
Relief
BISMUTH SUBSALICYLATE
1050 mg PER 30 mL
Upset Stomach Reliever/Antidiarrheal
Soothing relief for 5 symptoms:

• Heartburn
• Indigestion
• Upset stomach
• Nausea
• Diarrhea

Cherry Flavor

12 FL OZ (354 mL)

INGREDIENTS AND APPEARANCE

STOMACH RELIEF MAXIMUM STRENGTH 
bismuth subsalicylate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-005
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE)	BISMUTH SUBSALICYLATE	1050 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
BENZOIC ACID (UNII: 8SKN0B0MIM)
CHERRY (UNII: BUC5I9595W)
D&C RED NO. 22 (UNII: 1678RKX8RT)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
MAGNESIUM ALUMINUM SILICATE TYPE IC (UNII: XLI9KNX1FT)
METHYLCELLULOSE (4000 MPA.S) (UNII: MRJ667KA5E)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SALICYLIC ACID (UNII: O414PZ4LPZ)
SODIUM SALICYLATE (UNII: WIQ1H85SYP)
SORBIC ACID (UNII: X045WJ989B)
SUCRALOSE (UNII: 96K6UQ3ZD4)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	PINK (Pink to Bright Pink)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-005-40	354 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/20/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part335	01/20/2016

Labeler - CVS Pharmacy, Inc. (062312574)

Registrant - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurohealth LLC		078728447	MANUFACTURE(69842-005)