FIBER LAXATIVE - calcium polycarbophil tablet 
Topco Associates, LLC

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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Topcare Fiber Laxative

ACTIVE INGREDIENT (in each caplet)

Calcium polycarbophil 625 mg equivalent to 500 mg polycarbophil

PURPOSE

Bulk-forming laxative

USE(S)

  • relieves occasional constipation
  • this product 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.

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 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 over dose, get medical help or contact a Poison Control Center immediately.

DIRECTIONS

  • take this product (child or adult dose)  with a full glass or water (8oz.) or other fluid. Taking this product without enough liquid may cause chocking. 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 caplets, 1 to 4 times a day 
 children under 12 years  ask a doctor







OTHER INFORMATION

  • each caplet contains: calcium 135 mg
  • store at room temperature
  • protect contents from moisture

INACTIVE INGREDIENTS

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

PRINCIPAL DISPLAY PANEL

NDC 36800-465-27
Topcare`     
COMPARE TO FIBERCON ACTIVE INGREDIENT
Fiber Laxative

CALCIUM POLYCARBOPHIL 625 mg

BULK-FORMING LAXATIVE

  • Gentle Enough for Everyday Use
  • Just as Effective as Fiber Powders

DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING 
90 CAPLETS

81

FIBER LAXATIVE 
calcium polycarbophil tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-465
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)  
CARAMEL (UNII: T9D99G2B1R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
Product Characteristics
ColorWHITE (Off white) Scoreno score
ShapeCAPSULESize18mm
FlavorImprint Code G147
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-465-2790 in 1 BOTTLE; Type 0: Not a Combination Product08/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33408/01/2020
Labeler - Topco Associates, LLC (006935977)

Revised: 8/2018
 
Topco Associates, LLC