FIBER LAXATIVE CALCIUM POLYCARBOPHIL- calcium polycarbophil tablet 
Magno-Humphries, Inc.

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 Calcium Polycarbophil

MHL
NDC 54257-790-07

Compare to the active ingredient in Fibercon®*

FIBER LAXATIVE
CALCIUM POLYCARBOPHIL

  • RELIEVES CONSTIPATION
  • 280g of CALCIUM PER DOSE
  • GENTLE ENOUGH TO USE EVERDAY

90 TABLETS

DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

Active ingredient (in each tablet)

Calcium polycarbophil 625 mg
(Equivalent to 500 mg polycarbophil)

Purpose

Bulk-forming laxative

Uses

  • relieves occasional constipation to help restore and maintain regularity
  • 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, vomitting, 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 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 tablets in a 24 hour period unless directed by a doctor

​Stop use and ask a doctor if​ rectal bleeding occurs or if you fail to have a bowel movement after use of this or any other laxative. These could be signs of a serious condition.

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

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

​Adults and children over 12 years: ​2 tablets once a day up to 4 times a day.  ​Children under 12 years:​ ask a doctor

Other information

  • ​each tablet contains:​ 140 mg calcium
  • store at 20° to 25°C (68° to 77°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, stearic acid.

Questions?

call toll-free 1-800-935-6737

*This product is not manufactured or distributed by the owener of the registered trademark Fibercon®


Distributed by: Magno-Humphries, Inc., OR 97223 U.S.A.

​Visit our website: www.magno-humphries.com

*This product is not manufactured or distributed by the owener of the registered trademark Fibercon®

Distributed by: ​Magno-Humphries, Inc., OR 97223 U.S.A.

​Visit our website: www.magno-humphries.com

Package Labeling:

Label

Drug Facts

FIBER LAXATIVE CALCIUM POLYCARBOPHIL 
calcium polycarbophil tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54257-790
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, UNSPECIFIED (UNII: 2S7830E561)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
Colorwhite (off-white to cream) Score2 pieces
ShapeOVALSize19mm
FlavorImprint Code CPC339
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54257-790-0790 in 1 BOTTLE; Type 0: Not a Combination Product04/04/201707/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33404/04/201707/31/2020
Labeler - Magno-Humphries, Inc. (063251433)

Revised: 11/2020
 
Magno-Humphries, Inc.