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Fiber Lax by Rugby Laboratories

Dosage form: tablet, film coated
Ingredients: CALCIUM POLYCARBOPHIL 625mg
Labeler: Rugby Laboratories
NDC Code: 0536-4306

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.

Fiber-Lax Calcium Polycarbophil

Drug Facts

Active ingredient

(in each captab)

Calcium polycarbophil 625 mg

Purpose

Bulk-Forming Laxative

(equivalent to polycarbophil 500 mg)

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 medical 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 Control 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 140 mg
  • store below 30˚C (86˚F) • 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 or comments?

Call 1-800-645-2158, 9 am - 5 pm 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FIBER LAX 
calcium polycarbophil tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-4306
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM POLYCARBOPHIL (POLYCARBOPHIL) CALCIUM POLYCARBOPHIL625 mg
Inactive Ingredients
Ingredient NameStrength
CARAMEL 
CROSPOVIDONE 
HYPROMELLOSES 
MAGNESIUM SILICATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
MINERAL OIL 
POLYETHYLENE GLYCOL 
SILICON DIOXIDE 
SODIUM LAURYL SULFATE 
STEARIC ACID 
Product Characteristics
ColorWHITE (Off-white) Score2 pieces
ShapeOVALSize19mm
FlavorImprint CodeCPC;339
Contains    
Packaging
#Item CodePackage Description
1NDC:0536-4306-082 BLISTER PACK (BLISTER PACK) in 1 CARTON
130 TABLET, FILM COATED (TABLET) in 1 BLISTER PACK
2NDC:0536-4306-1190 TABLET, FILM COATED (TABLET) in 1 BOTTLE
3NDC:0536-4306-05500 TABLET, FILM COATED (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33409/01/2010
Labeler - Rugby Laboratories (109178264)
Registrant - Contract Pharmacal Corp (968334974)
Establishment
NameAddressID/FEIOperations
Contract Pharmacal Corp968334974MANUFACTURE(0536-4306)

Revised: 03/2012
 
Rugby Laboratories

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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