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STOMACH RELIEF by Chain Drug Consortium, LLC

Medically reviewed on December 21, 2017

Dosage form: liquid
Ingredients: BISMUTH SUBSALICYLATE 262mg in 15mL
Labeler: Chain Drug Consortium, LLC
NDC Code: 68016-392

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.

PV PEPTO

Active ingredient (in each 15 mL Tablespoonful)

Bismuth subsalicylate 262 mg

Purposes

upset stomach reliever and antidiarrheal

Uses

relieves

  • diarrhea
  • upset stomach due to overindulgence in food and drink, including:
  • heartburn
  • indigestion
  • nausea

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.

Directions
  • shake well before using
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • for accurate dosing, use dose cup
  • adults and children 12 years and over: take 2 tablespoonfuls every ½ to 1 hour as needed
  • do not exceed 16 tablespoonfuls in 24 hours
  • children under 12 years: ask a doctor

Other information
  • each tablespoonful contains: sodium 6 mg, salicylate 130 mg
  • low sodium
  • sugar free
  • protect from freezing
  • avoid excessive heat (over 104°F or 40°C)
  • visit www.info-xtra.com for health information
  • TAMPER-EVIDENT: Do not use if imprinted neckband is missing or broken

Inactive ingredients

benzoic acid, flavor, magnesium aluminum silicate, methylcellulose,
purified water, red 22, red 28, saccharin sodium, salicylic acid, simethicone emulsion,
sodium salicylate, sorbic acid, xanthan gum

package Label

STOMACH RELIEF 
bismuth subsalicylate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-392
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (SALICYLIC ACID and BISMUTH CATION) BISMUTH SUBSALICYLATE262 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID 
D&C RED NO. 22 
D&C RED NO. 28 
MAGNESIUM ALUMINUM SILICATE 
METHYLCELLULOSE (100 CPS) 
WATER 
SACCHARIN SODIUM (SACCHARIN)  
SALICYLIC ACID 
DIMETHICONE 
SODIUM SALICYLATE 
SORBIC ACID 
XANTHAN GUM 
METHYL SALICYLATE 
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68016-392-08237 mL in 1 BOTTLE
2NDC:68016-392-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33509/01/2014
Labeler - Chain Drug Consortium, LLC (101668460)
Registrant - GCP Laboratories (965480861)
Establishment
NameAddressID/FEIOperations
GCP LABORATORIES965480861manufacture(68016-392), pack(68016-392)

 
Chain Drug Consortium, LLC

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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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