FIBERCON- calcium polycarbophil tablet

FIBERCON by

Drug Labeling and Warnings

FIBERCON by is a Otc medication manufactured, distributed, or labeled by Wyeth Pharmaceutical Division of Wyeth Holdings LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each caplet)	Purpose
Calcium polycarbophil 625 mg equivalent to 500 mg polycarbophil	Bulk-forming laxative

INDICATIONS & USAGE

Uses

• relieves occasional constipation to help restore and maintain regularity
• this product generally produces bowel movement in 12 to 72 hours

WARNINGS

Warnings

Choking:

Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention.

Ask a doctor before use if you have

• abdominal pain, nausea, or vomiting
• a sudden change in bowel habits that persists over a period of 2 weeks

Ask a doctor or pharmacist before use if you are

taking any other drug. Take this product 2 or more hours before or after other drugs. All laxatives may affect how other drugs work.

When using this product

• do not use for more than 7 days unless directed by a doctor
• do not take more than 8 caplets in a 24 hour period unless directed by a doctor

Stop use and ask a doctor if

rectal bleeding occurs or if you fail to have a bowel movement after use of this or any other laxative. These could be signs of a serious condition.

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION

Directions

• take each dose of this product with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. See choking warning.
• FiberCon works naturally so continued use for one to three days is normally required to provide full benefit. Dosage may vary according to diet, exercise, previous laxative use or severity of constipation.

age	recommended dose	daily maximum
adults and children 12 years of age and over	2 caplets once a day	up to 4 times a day
children under 12 years	consult a physician

SPL UNCLASSIFIED SECTION

Other information

• each caplet contains: 140 mg calcium and 10 mg magnesium
• protect contents from moisture
• store at 20-25°C (68-77°F)

INACTIVE INGREDIENT

Inactive ingredients

caramel, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, sodium lauryl sulfate

QUESTIONS

Questions or comments?

Call weekdays from 9 AM to 5 PM EST at 1-800-282-8805

PRINCIPAL DISPLAY PANEL - 36 Caplet Blister Pack Carton

FiberCon®

Calcium Polycarbophil Bulk-Forming Laxative

Fiber Therapy for Regularity

• Gentle Enough for
  Everyday Use*
• Won't Ferment to
  Cause Gas or Bloating
• As Effective as
  Fiber Powders

*when used as directed

CONVENIENT
TRAVEL PACK!

36 Caplets

INGREDIENTS AND APPEARANCE

FIBERCON 
calcium polycarbophil tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0005-2500
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM POLYCARBOPHIL (UNII: 8F049NKY49) (POLYCARBOPHIL - UNII:W25LM17A4W)	CALCIUM POLYCARBOPHIL	625 mg

Inactive Ingredients
Ingredient Name	Strength
CARAMEL (UNII: T9D99G2B1R)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Product Characteristics
Color	BROWN	Score	2 pieces
Shape	OVAL	Size	18mm
Flavor		Imprint Code	LL;F1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0005-2500-02	9 in 1 CARTON	01/05/2004
1		4 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 0005-2500-33	1 in 1 CARTON	01/05/2004
2		90 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 0005-2500-23	140 in 1 BOTTLE; Type 0: Not a Combination Product	01/05/2004

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	01/05/2004

Labeler - Wyeth Pharmaceutical Division of Wyeth Holdings LLC (054065909)