FIBER LAXATIVE- calcium polycarbophil tablet 
Safeway

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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Fiber Laxative

Active ingredient (in each caplet)

Calcium polycarbophil 625 mg equivalent to 500 mg polycarbophil

Purpose

Bulk-forming laxative

uses

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
  • difficulty in swallowing
  • 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 
  • you experience chest pain, abdominal pain, nausea, vomiting, difficulty in breathing or swallowing
  • 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 immediately.

Directions

 adults and children 12 years and over                                                                  2 caplets, 1 to 4 times a day                                            
 Children under 12 years  ask a doctor

Other information

Inactive ingredients

Calcium carbonate, caramel, colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate

PDP

Compate to Fibercon active ingredient

Fiber Laxative

Calcium Polycarbophil 625mg

Fiber therapy for regularity

As effective as fiber powders

Bluk forming laxatives

140 caplets

Label

FIBER LAXATIVE 
calcium polycarbophil tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-147
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
CALCIUM CARBONATE (UNII: H0G9379FGK)  
COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSPOVIDONE (UNII: 68401960MK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
Product Characteristics
ColorwhiteScoreno score
ShapecapsuleSize19mm
FlavorImprint Code G147
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-147-94140 in 1 BOTTLE; Type 0: Not a Combination Product11/11/2015
2NDC:21130-147-2790 in 1 BOTTLE; Type 0: Not a Combination Product05/05/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33405/05/2015
Labeler - Safeway (009137209)
Establishment
NameAddressID/FEIBusiness Operations
Guardian Drug Company119210276manufacture(21130-147)

Revised: 1/2016
Document Id: 9f23e74c-875b-4344-8c90-34511a4d5e85
Set id: 507d1e11-4343-48b1-815d-2e8dd219fd9b
Version: 1
Effective Time: 20160121
 
Safeway