FIBER LAX- calcium polycarbophil tablet, film coated 
Bryant Ranch Prepack

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.

----------

0339-Rugby

Drug Facts

Active ingredient (in each tablet)
Calcium polycarbophil 625 mg
(equivalent to polycarbophil 500 mg)

Purpose

Purpose
Bulk-forming laxative

Uses

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours

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 Fiber-Lax two or more hours before or after other drugs. 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 tablets in a 24-hour period unless directed by a doctor

Stop use and ask a doctor if

• you fail to have a bowel movement after use or have rectal bleeding.

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 (1-800-222-1222) right away.

Directions

• take this product (child or adult dose) with a full glass of water (8oz.) or other fluid. Taking this product without enough liquid may cause choking. See choking warning

• dosage will vary according to diet, exercise, previous laxative use or severity of constipation

• continued use for 1 to 3 days is normally required to provide full benefit

adults and children 12 years and over2 tablets, 1 to 4 times per day
children under 12 yearsask a doctor

Other information

each tablet contains: calcium 140 mg

• do not use if printed seal under cap is torn or missing
• store in a dry place at 15° – 30°C (59° – 86°F).

• protect contents from moisture

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

*This product is not manufactured or distributed by GlaxoSmithKline, owner of the registered trademark FiberCon®

WARNING: This product can expose you to chemicals including lead, which is known to the State of California to cause cancer and birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.

Distributed by: Rugby Laboratories

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152

www. Rugbylaboratories.com

HOW SUPPLIED

Product: 63629-4436

NDC: 63629-4436-1 30 TABLET, FILM COATED in a BOTTLE

NDC: 63629-4436-2 60 TABLET, FILM COATED in a BOTTLE

NDC: 63629-4436-3 120 TABLET, FILM COATED in a BOTTLE

Fiber- Lax Polycarbo 500mg Tablet

Label Image
FIBER LAX 
calcium polycarbophil tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63629-4436(NDC:0536-4306)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM POLYCARBOPHIL (UNII: 8F049NKY49) (POLYCARBOPHIL - UNII:W25LM17A4W) CALCIUM POLYCARBOPHIL625 mg
Inactive Ingredients
Ingredient NameStrength
CARAMEL (UNII: T9D99G2B1R)  
CROSPOVIDONE (UNII: 2S7830E561)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
TALC (UNII: 7SEV7J4R1U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
Colorwhite (Off-white) Score2 pieces
ShapeOVALSize19mm
FlavorImprint Code CPC;339
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63629-4436-130 in 1 BOTTLE; Type 0: Not a Combination Product02/04/201111/27/2019
2NDC:63629-4436-3120 in 1 BOTTLE; Type 0: Not a Combination Product02/04/201111/27/2019
3NDC:63629-4436-260 in 1 BOTTLE; Type 0: Not a Combination Product02/04/201111/27/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33409/01/201011/27/2019
Labeler - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(63629-4436) , RELABEL(63629-4436)

Revised: 8/2021
 
Bryant Ranch Prepack