KONSYL SUGAR FREE ORANGE FLAVOR 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 Sugar Free Orange Flavor Psyllium Fiber

KONSYL Sugar Free Orange Flavor Psyllium Fiber

Active Ingredient (in each teaspoon)


Psyllium Hydrophilic Mucilloid 3.5 g

Purpose

  • Laxative

Uses

For relief of occasional constipation and to induce regularity. This product generally produces bowel movement 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 5.8g dose contains Potassium 25mg
  • Phenylketonurics: Contains phenylalanine, 21 mg per teaspoon
  • 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
  • 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

Inactive Ingredients

Aspartame, Citric Acid, FD and C Yellow No. 6, Maltodextrin, Natural and Artificial Orange Flavor, Silicon dioxide.

Questions or Comments?

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

Representative Labeling

Label

KONSYL SUGAR FREE ORANGE FLAVOR PSYLLIUM FIBER 
psyllium husk granule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0224-1855
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G) PSYLLIUM HUSK3.5 g  in 5.8 g
Inactive Ingredients
Ingredient NameStrength
ASPARTAME (UNII: Z0H242BBR1)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0224-1855-3030 in 1 BOX03/31/201101/01/2020
15.8 g in 1 PACKET; Type 0: Not a Combination Product
2NDC:0224-1855-8230 in 1 BOX03/31/201110/01/2019
25.8 g in 1 PACKET; Type 0: Not a Combination Product
3NDC:0224-1855-06300 g in 1 CANISTER; Type 0: Not a Combination Product03/31/201104/01/2020
4NDC:0224-1855-07450 g in 1 CANISTER; Type 0: Not a Combination Product03/31/201104/01/2020
5NDC:0224-1855-81450 g in 1 CANISTER; Type 0: Not a Combination Product03/31/201104/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/31/201104/01/2020
Labeler - Konsyl Pharmaceuticals, Inc. (102463866)
Establishment
NameAddressID/FEIBusiness Operations
Konsyl Pharmaceuticals, Inc. 102463866manufacture(0224-1855)

Revised: 12/2018
 
Konsyl Pharmaceuticals, Inc.