KONSYL FIBER- calcium polycarbophil capsule 
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 Fiber Caplets

Drug Facts

Active ingredient (in each caplet)

Calcium Polycarbophil 625 mg (equivalent to 500 mg polycarbophil)

Purpose

Bulk-forming laxative

Uses

• relieves occasional constipation • promotes 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 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. This laxative works naturally so continued use for one to three days is normally required to provide full benefit. Dosage may vary according to diet, exercise, previous laxative use or severity of constipation.

 adults and children 12
years of age and older
 Starting dose: 2 caplets once a day Maximum dose: 2 caplets four times a day or as directed by a doctor
 children under 12 years of age consult a doctor

Other information

each caplet contains: calcium 138 mg
• store at controlled room temperature, 68°F-77°F (20°C-25°C)
• protect contents from moisture 

Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

Inactive ingredients:

caramel, cellulose, crospovidone, hypromellose, magnesium silicate, magnesium stearate, mineral oil, PEG, silica, sodium lauryl sulfate, stearic acid. May also contain calcium carbonate, croscarmellose sodium, maltodextrin, talc.

Package Labeling:

New Label

KONSYL FIBER 
calcium polycarbophil capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0224-1889
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
CARAMEL (UNII: T9D99G2B1R)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
CROSPOVIDONE (UNII: 2S7830E561)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
Colorwhite (off white to cream-color, speckled) Score2 pieces
ShapeCAPSULESize19mm
FlavorImprint Code CPC;339
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0224-1889-0190 in 1 BOTTLE; Type 0: Not a Combination Product07/01/201907/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33407/01/201907/01/2021
Labeler - Konsyl Pharmaceuticals, Inc. (102463866)

Revised: 12/2020
 
Konsyl Pharmaceuticals, Inc.