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 dose)

Psyllium husk approx. 520 mg

Purpose

Bulk-forming laxative

Uses

  • for relief of occasional constipation (irregularity)
  • this product generally produces bowel movement in 12 to 72 hours

Warnings

Allergy Alert: This product may cause an allergic reaction in people sensitive to inhaled or ingested psyllium.

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

  • stomach pain, nausea, or vomiting
  • a sudden change in bowel habits that persists over 2 weeks

Stop use and ask a doctor if

  • you fail to have a bowel movement or have rectal bleeding.  These could be sings of a serious condition.
  • you need to use a laxative for more than 1 week 
  • 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 right away.

Directions

  • 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 below or use as directed by a doctor. - drink a full glass (8 oz) of water or other liquid with each dose - continued use for 1 to 3 days is normally required to provide full benefit

Other information

  • keep tightly closed
  • store at room temperature
  • contains a 100% natural therapeutic fiber

Inactive ingredients

FDandC yellow #6, gelatin. polyethylene glycol. polysorbate 80

Representative Labeling




Konsyl Natural Psyllium Fiber Outer

Konsyl2

KONSYL 100 PERCENT NATURAL PSYLLIUM FIBER 
psyllium husk capsule
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0224-1847
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSYLLIUM HUSK (PSYLLIUM HUSK) PSYLLIUM HUSK520 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 
GELATIN 
POLYSORBATE 80 
Product Characteristics
Colorwhite (CLEAR) Scoreno score
ShapeCAPSULESize21mm
FlavorImprint Code P620
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0224-1847-101 in 1 BOX
1100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/31/2011
Labeler - Konsyl Pharmaceuticals, Inc. (102463866)
Establishment
NameAddressID/FEIBusiness Operations
Konsyl Pharmaceuticals, Inc.102463866manufacture(0224-1847)

Revised: 9/2013
 
Konsyl Pharmaceuticals, Inc.