MAXIMUM STRENGTH STOMACH RELIEF- bismuth subsalicylate liquid 
CVS

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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Maximum Strength Stomach Relief

Active ingredient (in each 30 mL)

Bismuth subsalicylate 1050 mg

Purpose

Upset stomach reliever and anti-diarrheal


Uses

relieves:

Warnings

Reye's syndrome: Children and teenagers who have or are recovering from children 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

Do not use if you have

  • bloody or black stool
  • an ulcer
  • a bleeding problem

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 of 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  immediately.

Directions

Other information

Inactive ingredients

benzoic acid, D&C red 22, D&Cred 28, flavor, hydroxy ethyl cellulose, potassium hydroxide, purified water, saccharin sodium, salicylic acid, simethicone, xanthan gum.

Principal Display Panel

*Compare to the active ingredient in PEPTO-BISMOL® Maximum Strength

Maximum Strength Stomach Relief

Bismuth Subsalicylate 1050mg

Upset Stomach Reliever & Anti-diarrheal

Soothing Relief for 5 symptoms: 

Upset Stomach

Indigestion

Nausea

Heartburn

Diarrhea

12 FL OZ (355 mL)

Label

MAXIMUM STRENGTH STOMACH RELIEF 
bismuth subsalicylate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-528
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE525 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
D&C RED NO. 22 (UNII: 1678RKX8RT)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorWINTERGREENImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-528-05355 mL in 1 BOTTLE; Type 0: Not a Combination Product09/08/2008
2NDC:69842-528-04236 mL in 1 BOTTLE; Type 0: Not a Combination Product09/08/2008
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33509/08/2008
Labeler - CVS (062312574)

Revised: 8/2017
Document Id: 6e37d3f7-9589-427c-ae57-03b39833caf9
Set id: 75326a55-7cf3-411e-96a3-a6aef6c35ca5
Version: 1
Effective Time: 20170808
 
CVS