KONSYL DAILY THERAPY FIBER- calcium polycarbophil tablet 
Konsyl Pharmaceuticals, 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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KONSYL Daily Therapy Fiber Caplets

Active Ingredient

Active Ingredient (in each caplet)                                                                          
Calciumpolycarbophil 625mg equivalent to 500 mg polycatophil.......................

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.

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

Keep out of the 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
2 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

Storage and Handling

Store at room temeperature.  Protect contents from moisture

Inactive ingredients

CALCIUM CARBONATE, CARAMEL, COLLOIDAL SILICON DIOXIDE, CROSPOVIDONE, HYDROXYPROPYLMETHYLCELLULOSE, MAGNESIUM STEARATE, MICROCRYSTALLINE CELLULOSE, POLYETHYLENE GLYCOL, SODIUM LAURYL SULFATE.

Adverse Reactions

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

Purpose

Bulk-forming laxative

KONSYL  DAILY THERAPY  FIBER CAPLETS  LAXATIVE  Sugar Free Convenient Easy to swallow   90 Caplets   625mg Calcium Polycarbophill   SAFETY SEALED PACK/CONTAINER   DO NOT USE IF THE SEAL UNDER THE CAP IS BROKEN OR MISSING

KONSYL Daily Therapy Fiber Caplets 90 Caplets (0224-0500-90)

Konsyl Caplet 1

Drug Facts (continued)   DISTRIBUTED BY:  KONSYL PHARMACEUTICALS, INC.  EASTON, MD 21601

Konsyl Caplet 2

KONSYL DAILY THERAPY FIBER 
calcium polycarbophil tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem 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 Code G147
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0224-0500-9090 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/FEIBusiness Operations
Konsyl Pharmaceuticals, Inc.102463866manufacture(0224-0500)

Revised: 8/2013
 
Konsyl Pharmaceuticals, Inc.