FIBER LAX - calcium polycarbophil tablet 
NCS HealthCare of KY, Inc dba Vangard Labs

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Fiber-Lax Captabs

Active ingredient(s)

Calcium Polycarbophil 625mg (equivalent to polycarbophil 500mg)

Purpose

Bulk-Forming Laxative

Use(s)

- relieves occasional constipation

- 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 attention.

Do not use for longer than one week.

Ask a doctor or pharmacist before use if

Ask a doctor before use if you have

-abdominal pain, nausea, or vomiting

-noticed a sudden change in bowel habits that lasts over two weeks

Ask a doctor or pharmacist before use if you are taking any other drug. Take Fiber-Lax two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Stop use and ask a doctor if

Stop use and ask a doctor if

-you have rectal bleeding

-you fail to have a bowel movement after using this product. These may indicate a serious condition.

Keep out of reach of children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Center right away.

Directions

Take Fiber-Lax 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.

-take dose 1-4 times daily - do not take more than 4 doses in 24 hours.

-adults & children 12 years and over: 2 captabs

-children under 12 years: ask a doctor

Other information

-each captab contains: calcium 140mg

Storage

-store below 30 degrees C (86 degrees F)

-do not refrigerate

-protect from humidity

Inactive ingredients

Anhydrous lactose, caramel powder, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium lauryl and stearic acid.

Questions

Questions and Comments?

Call 1-800-645-2158, 9am - 5pm ET, Monday - Friday

Principal Display Panel

Fiber-Lax Captabs

FIBER LAX  fiber lax   tablet

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0615-5532 (0536-4306) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM POLYCARBOPHIL (CALCIUM) CALCIUM POLYCARBOPHIL 500 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE   SILICON DIOXIDE   HYPROMELLOSE   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   POLYETHYLENE GLYCOL   SODIUM LAURYL SULFATE   STEARIC ACID   CARAMEL

Product Characteristics Color WHITE (Beige) Score 2 pieces Shape CAPSULE (Oblong Bisect) Size 19mm Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0615-5532-31 31 TABLET In 1 BLISTER PACK None 2 0615-5532-39 30 TABLET In 1 BLISTER PACK None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part334	07/01/2010

Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)

Establishment
Name	Address	ID/FEI	Operations
NCS HealthCare of KY, Inc dba Vangard Labs		050052943	RELABEL, REPACK

Revised: 07/2010NCS HealthCare of KY, Inc dba Vangard Labs