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

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Fiber Laxative

Drug Facts

Active ingredient (in each tablet)

Calcium polycarbophil 625 mg (Equivalent to 500 mg polycarbophil)

Purpose

Bulk-forming laxative

Uses

Warnings

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. Choking:

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 tablets in a 24 hour period unless directed b y 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 (1-800-222-1222) right away.

Directions

Other information

Inactive ingredients

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

Questions?

call toll-free 1-800-935-6737

Package Labeling:

Label3

FIBER LAXATIVE 
calcium polycarbophil tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54257-379
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 (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
ShapeOVALSize20mm
FlavorImprint Code G147
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54257-379-0790 in 1 BOTTLE; Type 0: Not a Combination Product01/24/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00701/24/2020
Labeler - Magno-Humphries, Inc. (063251433)

Revised: 10/2023
Document Id: 08bf29ff-1c8c-1547-e063-6294a90ac7ee
Set id: 9d22c208-d089-8b6a-e053-2995a90ab90a
Version: 3
Effective Time: 20231027
 
Magno-Humphries, Inc.