FIBER TABS

Dosage form: tablet
Ingredients: CALCIUM POLYCARBOPHIL 500mg
Labeler: Major Pharmaceuticals
NDC Code: 0904-2500

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.

Fibercon
(calcium polycarbophil)

DRUG FACTS

ACTIVE INGREDIENT (IN EACH TABLET)

Calcium polycarbophil 625 mg equivalent to 500 mg polycarbophil

PURPOSE

Bulk-forming fiber 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, 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 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

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 overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS
  • take each dose of this product with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. See Choking warning.
  • Do not take more than 4 doses in 24 hours
agerecommended dosedaily maximum
 adults and children 12 years of age and over 2 tablets  1 to 4 times a day
 children under 12 years consult a physician  

OTHER INFORMATION
  • each tablet contains: 140 mg calcium
  • protect contents from moisture
  • store at room temperature, USP
  • do not use if imprinted safety seal under cap is broken or missing

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?

To report side effects call: 1-800-616-2471

PRINCIPAL DISPLAY PANEL

Fiber-Tabs

Calcium Polycarbophil Bulk-Forming Fiber Laxative

90 Tablets

Distributed by: Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150  USA

FIBER TABS 
calcium polycarbophil tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-2500
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM POLYCARBOPHIL (POLYCARBOPHIL) POLYCARBOPHIL500 mg
Inactive Ingredients
Ingredient NameStrength
CARAMEL 
CELLULOSE, MICROCRYSTALLINE 
CROSPOVIDONE 
HYPROMELLOSES 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOLS 
SODIUM LAURYL SULFATE 
MAGNESIUM SILICATE 
LIGHT MINERAL OIL 
12-HYDROXYSTEARIC ACID 
Product Characteristics
ColorGRAY (Off white to grayish color depending on lighting) Score2 pieces
ShapeOVALSize20mm
FlavorImprint CodeCPC;339
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-2500-9190 TABLET (90 TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33409/09/2010
Labeler - Major Pharmaceuticals (191427277)

Revised: 09/2012
 
Major Pharmaceuticals

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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