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STOMACH RELIEF MAXIMUM STRENGTH

Medically reviewed on January 27, 2017

Dosage form: liquid
Ingredients: BISMUTH SUBSALICYLATE 1050mg in 30mL
Labeler: CVS Pharmacy, Inc.
NDC Code: 69842-005

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.

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)



STOMACH RELIEF MAXIMUM STRENGTH 
bismuth subsalicylate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-005
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (SALICYLIC ACID and BISMUTH CATION) BISMUTH SUBSALICYLATE1050 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID 
CHERRY 
D&C RED NO. 22 
D&C RED NO. 28 
MAGNESIUM ALUMINUM SILICATE TYPE IC 
METHYLCELLULOSE (4000 MPA.S) 
SACCHARIN SODIUM 
SALICYLIC ACID 
SODIUM SALICYLATE 
SORBIC ACID 
SUCRALOSE 
WATER 
XANTHAN GUM 
Product Characteristics
ColorPINK (Pink to Bright Pink) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:69842-005-40354 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33501/20/2016
Labeler - CVS Pharmacy, Inc. (062312574)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIOperations
Aurohealth LLC078728447MANUFACTURE(69842-005)

 
CVS Pharmacy, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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