PEPBIS REGULAR- bismuth subslicylate suspension

Pepbis by

Drug Labeling and Warnings

Pepbis by is a Otc medication manufactured, distributed, or labeled by KC Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Bismuth subsalicylate, 262 mg

Purpose

Bismuth subsalicylate - Upset stomach reliever and Antidiarrheal

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center immediately.

Uses

• upset stomach
• indigestion
• nausea
• heartburn
• diarrhea
  

Warnings

Reye's Syndrome: Children and teenagers who have or are recovering from chicken pox, flu symptoms, or flu should NOT use this product.  If nausea, vomiting or fever occur, consult a doctor because these symptoms could be an early sign of Reye Syndrom, a rare but serious illness.

Allergy Alert: do not take this product if you are allergic to salicylates (including aspirin) unless directed by a doctor.

Do not use for diarrhea on children under 3 years of age

Ask a doctor or a pharmacist before use if you are taking prescription medicines for anticoagulation (thinning of the blood), diabetes, gout or arthritis.

Stop use and ask a doctor if

• you are taking this product with other salicylate-containing preparations (such as aspirin) and ringing in the ears occurs.  This product contains salicylate.
• diarrhea is accompanied by a high fever or continues for more than 2 days
• other symptoms last more than 2 weeks
  

Directions

• Shake well before use
• For convenience, use the dosage cup

• adults and children 12 yrs and over: 2 Tbsp or 30 mL
• children 9 to under 12 years: 1 Tbsp or 15 mL
• children 6 to under 9 years: 2 tsp or 10 mL
• children 3 to under 6 years: 1 tsp or 5 mL
• children under 3 years: consult a doctor

• Repeat above dosage every 1/2 to 1 hour as needed to a maximum of 8 doses in a 24-hour period
  

Inactive Ingredients

FD and C Red No. 3, FD and C Red No. 40, flavor, magnesium aluminum silicate, methylcellulose, saccharin sodium, salicylic acid, sodium salicylate, and water

Other information

• Do not use if imprinted safety seal around the dosage cup and bottle is broken or missing
• each tablespoon (15 mL) contains: sodium 1 mg
• each tablespoon (15 mL) contains: salicylate 130 mg
• sugar free
• low in sodium
• avoid excessive heat (over 104oF or 40oC)
• protect from freezing
• may cause a temporary and harmless darkening of the tongue or stool
  

If pregnant or breast-feeding

ask a health professional before use.

Principal Display Panel

PBRG

INGREDIENTS AND APPEARANCE

PEPBIS  REGULAR
bismuth subslicylate suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55651-264
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH SUBSALICYLATE - UNII:62TEY51RR1)	BISMUTH SUBSALICYLATE	17.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
FD&C RED NO. 40 (UNII: WZB9127XOA)
METHYL SALICYLATE (UNII: LAV5U5022Y)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
METHYLCELLULOSE (400 CPS) (UNII: O0GN6F9B2Y)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SALICYLIC ACID (UNII: O414PZ4LPZ)
SODIUM SALICYLATE (UNII: WIQ1H85SYP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55651-264-01	237 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part335	03/04/2004

Labeler - KC Pharmaceuticals, Inc. (174450460)

Establishment
Name	Address	ID/FEI	Business Operations
KC Pharmaceuticals, Inc.		174450460	manufacture