KA PEC - bismuth subsalicylate liquid 
Rij Pharmaceutical Corporation

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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Drug Facts

Active ingredient (in each tablespoon= 15 mL)

Bismuth subsalicylate 262 mg

Purpose

Anti-diarrheal

Uses

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
  • if you have an ulcer or bleeding problem

Ask a doctor before use if you have

  • fever
  • mucus in the stool
  • a magnesium-restricted diet
  • a sodium-restricted diet

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

Inactive ingredients

Carboxymethylcellulose sodium, flavor, glycerin, magnesium aluminum silicate, saccharin sodium, salicylic acid, sodium benzoate, sodium saliycylate, sorbitol, water

Other information

Principal Display Panel

Bismuth label

KA PEC  
bismuth subsalicylate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53807-515
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE262 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
GLYCERIN (UNII: PDC6A3C0OX)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM SALICYLATE (UNII: WIQ1H85SYP)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53807-515-12355 mL in 1 BOTTLE; Type 0: Not a Combination Product03/16/1999
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33503/16/1999
Labeler - Rij Pharmaceutical Corporation (144679156)
Establishment
NameAddressID/FEIBusiness Operations
Rij Pharmaceutical Corporation144679156manufacture(53807-515)

Revised: 4/2018
Document Id: 16b35a30-e334-4aa4-98aa-43cf9bd49ed4
Set id: fdfbd304-d7a3-48f0-966c-23823a4399c9
Version: 2
Effective Time: 20180430
 
Rij Pharmaceutical Corporation