Ka Pec: Package Insert and Label Information

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.

Active ingredient (in each tablespoon= 15 mL)

Bismuth subsalicylate 262 mg

Purpose

Anti-diarrheal

Uses

  • controls diarrhea
  • reduce number of bowel movements
  • help firm stool

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

  • allergic to salicylates (including aspirin)
  • taking other salicylate products

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

  • Drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • shake well before using
  • repeat dosage every 1/2 to 1 hour as needed
  • do not take more than 8 doses in 24 hours
  • use until diarrhea stops but not more than 2 days
  • adults & children 12 years and over: 2 tablespoons (30 mL)
  • children under 12 years: ask a doctor

Inactive ingredients

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

Other information

  • Store at room temperature. Protect from freezing and excessive heat (over 40o C or 104o F)
  • each tablespoon (15 mL) contains: magnesium 32 mg
  • each tablespoon (15 mL) contains: sodium 24 mg
  • TAMPER EVIDENT: DO NOT USE IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING.

Principal Display Panel

Bismuth label
(click image for full-size original)

KA PEC
bismuth subsalicylate liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53807-515
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BISMUTH SUBSALICYLATE (BISMUTH CATION) BISMUTH SUBSALICYLATE 262 mg in 15 mL
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE SODIUM
GLYCERIN
MAGNESIUM ALUMINUM SILICATE
SACCHARIN SODIUM
SALICYLIC ACID
SODIUM BENZOATE
SODIUM SALICYLATE
SORBITOL
WATER
Product Characteristics
Color pink Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53807-515-12 355 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part335 03/16/1999
Labeler — Rij Pharmaceutical Corporation (144679156)
Establishment
Name Address ID/FEI Operations
Rij Pharmaceutical Corporation 144679156 manufacture (53807-515)

Revised: 04/2018 Rij Pharmaceutical Corporation

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