KONSYL ORIGINAL FORMULA PSYLLIUM FIBER  - psyllium husk granule 
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 Original Formula Psyllium Fiber

Konsyl Original Formula Psyllium Fiber

Active Ingredients (in each teaspoon)

Psyllium Hydrophilic Mucilloid 6g

Purpose

Laxative

Uses

For relief of occasional constipation and to induce regularity.

This product generally produces bowel movements within 12-72 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

Mix this product with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough fluid may cause choking. See choking warning.

 

adults and children 12 years and older |one teaspoon 1 to 3 times daily

children 6 to under 12 years of age      | 1/2 teaspoon 1 to 3 times daily

children under 6 years of age               | consult a doctor

Other Information

  • each 6g dose contains: Potassium 50mg
  • laxatives, including bulk fibers, may affect how other 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
  • do not discard Konsyl into any plumbing system
  • store below 86 degrees F (30 degrees C)
  • keep container tightly closed-protect from excessive moisture
  • can be taken before or after meals, mornings or evenings

Questions or comments?

  • 1-800-356-6795  8:30 a.m to 5 p.m. ET.

Representative Labeling

Konsyl_1801_80

KONSYL ORIGINAL FORMULA PSYLLIUM FIBER  
psyllium husk granule
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0224-1801
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSYLLIUM HUSK (PSYLLIUM HUSK) PSYLLIUM HUSK6 g  in 6 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0224-1801-3530 in 1 BOX
16 g in 1 PACKET
2NDC:0224-1801-07450 g in 1 CANISTER
3NDC:0224-1801-81450 g in 1 CANISTER
4NDC:0224-1801-06300 g in 1 CANISTER
5NDC:0224-1801-80300 g in 1 CANISTER
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(0224-1801)

Revised: 9/2013
 
Konsyl Pharmaceuticals, Inc.