KONSYL 100 PERCENT NATURAL PSYLLIUM FIBER- psyllium husk 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 100% Natural Psyllium Fiber Capsules

KONSYL 100% Natural Psyllium Fiber Capsules

Active ingredient (in each capsule)

Psyllium husk approx. 20 mg

Purpose

Laxative

Uses

  • for relief of occasional constipation  and to induce regularity. This product generally produces bowel movement  within 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

  • when abdominal pain, nausea or vomiting are present unless directed by a doctor
  • If constipation lasts more than seven days
  • if you have difficulty swallowing

Ask a doctor before use if you have

  • noticed a sudden change in bowel habits that persists over a period of 2 weeks

Stop use and ask a doctor if

  • you experience rectal bleeding or fail to have a bowel movement, as these may 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



adults and children 12 years and over
5 capsules one to three times daily
children under 12 years
consult a doctor

  • Take this product (child or adult dose) with at least 8 ounces (a full glass0 of water or other fluid. Taking this product without enough liquid may cause choking. See choking warning.
  • follow dosage above or use as directed by a doctor

Other information

  • laxatives, including bulk fibers, may affect how other medicines work, wait 1-2 hours before or after taking other medicines
  • tamper-evident bottle mouth sealed for your protection
  • do not use if imprinted inner seal is broken or missing
  • store below 86  degrees F (30 degrees C)
  • can be taken before or after meals, mornings or evenings

Inactive ingredients

FDandC yellow 6, gelatin. polyethylene glycol, polysorbate 80

Representative Labeling

Label

KONSYL 100 PERCENT NATURAL PSYLLIUM FIBER 
psyllium husk capsule
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0224-1847
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G) PSYLLIUM HUSK 20 mg
Inactive Ingredients
Ingredient Name Strength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
Product Characteristics
Color white (CLEAR) Score no score
Shape CAPSULE Size 21mm
Flavor Imprint Code P620
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0224-1847-80 1 in 1 BOX 03/31/2011 07/01/2019
1 100 in 1 BOTTLE; Type 0: Not a Combination Product
2 NDC:0224-1847-10 1 in 1 BOX 03/31/2011 07/01/2019
2 100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 03/31/2011 07/01/2019
Labeler - Konsyl Pharmaceuticals, Inc. (102463866)
Establishment
Name Address ID/FEI Business Operations
Konsyl Pharmaceuticals, Inc. 102463866 manufacture(0224-1847)

Revised: 12/2018
Konsyl Pharmaceuticals, Inc.