FIBERCON- calcium polycarbophil tablet
Wyeth Pharmaceutical Division of Wyeth Holdings Corporation, a subsidiary of Pfizer Inc.

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 CAPLET)

Calcium polycarbophil 625 mg equivalent to 500 mg polycarbophil

PURPOSE

Bulk-forming laxative

USES

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

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.

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

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 INGREDIENTS

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

QUESTIONS OR COMMENTS?

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

PRODUCT PACKAGING

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

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

For most recent product information, visit www.fibercon.com.

Product inside sealed in plastic blister with foil backing. Do Not Use if plastic blister or foil barrier is broken.

FIBERCON
calcium polycarbophil tablet

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
calcium polycarbophil (calcium polycarbophil)	calcium polycarbophil	625 mg

Inactive Ingredients
Ingredient Name	Strength
caramel
cellulose, microcrystalline
crospovidone
hypromelloses
magnesium stearate
polyethylene glycols
silicon dioxide
sodium lauryl sulfate

Product Characteristics
Color	GRAY (Off white to grayish color depending on lighting)	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code
Contains	140 mg Calcium, 10 mg Magnesium (140 mg Calcium, 10 mg Magnesium )

Packaging
#	Item Code	Package Description
1	NDC:0005-2500-02	9 in 1 CARTON
1		4 in 1 BLISTER PACK
2	NDC:0005-2500-33	1 in 1 CARTON
2		90 in 1 BOTTLE
3	NDC:0005-2500-23	140 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part334	01/05/2004

Labeler - Wyeth Pharmaceutical Division of Wyeth Holdings Corporation, a subsidiary of Pfizer Inc. (054065909)

Establishment
Name	Address	ID/FEI	Business Operations
Perrigo Company Corp.		006013346	MANUFACTURE

Revised: 09/2011

Document Id: 4de6dc3f-d845-a594-4f11-c000340b8b76

Set id: 80e507f2-d9bd-bc7b-2249-f5bfc8ac1845

Version: 3

Effective Time: 20110915

Wyeth Pharmaceutical Division of Wyeth Holdings Corporation, a subsidiary of Pfizer Inc.