FIBER LAX- calcium polycarbophil tablet, film coated
NCS HealthCare of KY, LLC dba Vangard Labs

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 captab)

Calcium polycarbophil 625mg

Purpose

Bulk-Forming Laxative

(equivalent to polycarbophil 500mg)

Uses

∙ 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

longer than one week

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

∙ 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

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.

∙ do not take more than 4 doses in 24 hours.

∙ adults & children 12 years and over: 2 captabs 1 to 4 times a day

∙ children under 12 years: ask a doctor

Other information

∙ each captab contains: calcium 140mg

∙ store below 30⁰C (86⁰F) ∙ do not refrigerate ∙ protect from humidity

Inactive ingredients

Caramel, crospovidone, hypromellose, magnesium silicate, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, silica, sodium lauryl sulfate and stearic acid.

Questions and Comments?

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

TAMPER EVIDENT: DO NOT USE IF BLISTER SEAL IS BROKEN OR DAMAGED

*Rugby Laboratories, Inc. is not affiliated with the owner of the trademark

FiberCon®.

Fiber-Lax is distributed by Rugby Laboratories, Inc.

Rugby ®

Duluth, Georgia 30097

www.Rugbylaboratories.com

Principal Display Panel

Fiber-Lax Captabs

FIBER LAX
calcium polycarbophil tablet, film coated

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

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

Ingredient Name	Strength
Inactive Ingredients
CROSPOVIDONE (UNII: 2S7830E561)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STEARIC ACID (UNII: 4ELV7Z65AP)
CARAMEL (UNII: T9D99G2B1R)
MAGNESIUM SILICATE (UNII: 9B9691B2N9)
MINERAL OIL (UNII: T5L8T28FGP)

Product Characteristics
Color	white ((Off-White))	Score	2 pieces
Shape	OVAL	Size	19mm
Flavor		Imprint Code	CPC;339
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0615-5532-31	31 in 1 BLISTER PACK; Type 0: Not a Combination Product	12/31/2010	02/28/2018
2	NDC:0615-5532-39	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	12/31/2010	02/28/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	09/01/2010	02/28/2018

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

Name	Address	ID/FEI	Business Operations
Establishment
NCS HealthCare of KY, LLC dba Vangard Labs		050052943	repack(0615-5532)

Revised: 5/2021

Document Id: 2d72f560-cb58-4397-84ab-2aae7ac22229

Set id: a36eb503-f6be-4b9f-be33-0424a3d3f3e3

Version: 17

Effective Time: 20210514

NCS HealthCare of KY, LLC dba Vangard Labs