FiberTab

Dosage form: tablet
Ingredients: CALCIUM POLYCARBOPHIL 625mg
Labeler: Qualitest Pharmaceuticals
NDC Code: 0603-0181

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.

FiberTab

ACTIVE INGREDIENTS (IN EACH CAPLET)

Calcium Polycarbophil 625mg (equivalent to 500mg polycarbophil)

PURPOSE

Laxative

USES
  • relieves constipation
  • helps restore and maintain regularity
  • this product generally produces a 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 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 more than 7 days unless directed by a doctor
  • do not take caplets more than 4 times in a 24 hour period unless directed by a doctor

Stop use and ask a doctor if
  • rectal bleeding occurs
  • 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 immediately.

DIRECTIONS
  • take 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.
  • this product works naturally so continued use for 1 to 3 days is normally required to provide full benefit. Dosage may vary according to diet, exercise, previous laxative use or severity of constipation.
AgeRecommended DosageDaily Maximum
Adults & children over 122 caplets once a dayUp to 4 times a day
Children under 12 yearsConsult a doctor

OTHER INFORMATION
  • store at 68°-77°F (20°-25°C)
  • protect from excessive moisture
  • do not use if imprinted safety seal under cap is broken or missing
  • Each caplet contains 125mg calcium

INACTIVE INGREDIENTS

caramel color, croscarmellose sodium, hydroxypropyl methylcellulose, microcrystalline cellulose, polyethylene glycol, silicon dioxide, talc.

PRINCIPAL DISPLAY PANEL

Product Label

Bulk-Forming Laxative

  • Natural Relief of Constipation
  • Helps Restore & Maintain Regularity

Made in the USA for

Qualitest Pharmaceuticals Inc.

Huntsville, AL 35811

FIBERTAB 
calcium polycarbophil tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0603-0181
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM POLYCARBOPHIL (POLYCARBOPHIL) CALCIUM POLYCARBOPHIL625 mg
Inactive Ingredients
Ingredient NameStrength
CARAMEL 
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
SILICON DIOXIDE 
TALC 
Product Characteristics
Colorwhite (beige) Scoreno score
ShapeCAPSULE (caplet) Size19mm
FlavorImprint CodeAZ221
Contains    
Packaging
#Item CodePackage Description
1NDC:0603-0181-0290 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/10/2005
Labeler - Qualitest Pharmaceuticals (011103059)
Registrant - A&Z Pharmaceutical, Inc. (926820705)
Establishment
NameAddressID/FEIOperations
A&Z Pharmaceutical, Inc.926820705manufacture(0603-0181), label(0603-0181)

Revised: 09/2012
 
Qualitest 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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