KONSYL Daily Therapy Fiber

Dosage form: tablet
Ingredients: CALCIUM POLYCARBOPHIL 625mg
Labeler: Konsyl Pharmaceuticals, Inc.
NDC Code: 0224-0500

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.

KONSYL Daily Therapy Fiber Caplets

KONSYL Daily Therapy Fiber Caplets

Active Ingredient (in each caplet)

Calcium polycarbophil 625 mg equivalent to 500 mg polycarbophil

Purpose

Laxative

Uses

relieves:

  • constipation
  • helps restore and maintain regularity
  • promotes normal function of the bowel
  • 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.

This product contains a chemical known to the State of California to cause birth defects or other reproductive harm.

Do not use if you are taking any form of tetracycline antibiotic.

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 drug 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
  • you experience chest pain, abdominal pain, nausea, vomiting, difficulty in breathing or swallowing
  • you fail to have bowel movement after use
  • rectal bleeding occurs

If pregnant or breast feeding, ask a health professional before use.

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center immediately.

Directions
  • Take this product (child or adult dose) with a full glass of water (8 oz.) or other fluid.  Taking this product without enough liquid may cause choking.  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 over 12 years
2 caplets, 1 to 4 times a day
children 6 to under 12 years
1 caplet, once a day
children under 6 years
ask a doctor

Other information
  • each caplet contains: calcium 135 mg
  • do not use if printed seal under cap is torn or missing
  • 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.

TO REPORT ADVERSE DRUG EVENTS CALL: 800-356-6795


Representative Labeling
KONSYL DAILY THERAPY FIBER 
calcium polycarbophil tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0224-0500
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM POLYCARBOPHIL (POLYCARBOPHIL) CALCIUM POLYCARBOPHIL625 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE 
CARAMEL 
SILICON DIOXIDE 
CROSPOVIDONE 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
SODIUM LAURYL SULFATE 
Product Characteristics
Colorwhite (Very Light Beige, Speckled) Scoreno score
ShapeBULLETSize19mm
FlavorImprint CodeG147
Contains    
Packaging
#Item CodePackage Description
1NDC:0224-0500-9090 TABLET (TABLET) in 1 BOTTLE
2NDC:0224-0500-8090 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/12/2012
Labeler - Konsyl Pharmaceuticals, Inc. (102463866)
Registrant - Konsyl Pharmaceuticals, Inc. (102463866)
Establishment
NameAddressID/FEIOperations
Konsyl Pharmaceuticals, Inc.102463866manufacture(0224-0500)

Revised: 01/2014
 
Konsyl Pharmaceuticals, Inc.

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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