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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Active ingredient (in each dose)                

Psyllium Hydrophilic Mucilloid 6 grams

 Purpose

Bulk-Forming Laxative

Use For relief of occasional constipation and to induce regularity, This product generally produces bowel movements within 12 to 72 hours.

Warnings  Allergy alert As with any natural grain product, inhaled or ingested psyllium powder may cause an allergic reaction in people sensitive to psyllium.

Do not use laxative products when abdominal pain, nausea or vomiting are present unless directed by a doctor.

Ask a doctor before use if you have  - a sudden change in bowel habits that persists over a period of two weeks

Stop use and ask a doctor if  - you experience rectal bleeding  - you fail to have a bowel movement

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 (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough fluid may cause choking. See choking warnings.  Adults and children 12 years and older:  sprinkle one dose (one rounded teaspoonful) into a shaker cup or closed container; with at least 8 oz. of juice, water or other beverage; shake 3 to 5 seconds; drink promptly; if mixture thickens, add more fluid stir; follow with additional fluid to aid product action; take 1-3 times daily.  Children 6 years to under 12 years:  1/ adult dose, in 8 oz. of fluid; 1-3 times daily.  Children under 6 years: ask a doctor.

Other information

- each 6.0 gram dose contains: Calcium 10mg, Potassium 55 mg, Sodium 5 mg.  - maximum daily dose (3 teaspoonfuls) is very low in sodium  - do not discard KONSYL  powder into any plumbing systems  - Laxatives, including bulk fibers, may affect how other medicines work, wait 1-2 hours before or after taking other medicines.  - no additives, No sugars, gluten free, No flavors, 100% Natural  - safe for diabetics, non habit-forming  - tamper-evident bottle mouth sealed for your protection  - do not use if imprinted inner seal is broken or missing  - store below 86 Degree F (30 Degree Centigrade)  - keep container tightly closed-protect from excessive moisture  - can be taken 1 to 3 times daily, before or after meals, mornings or evenings

  • Inactive Ingredients  None

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

Konsyl Original Formula Psyllium Fiber Sachet

Konsyl Original Formula Psyllium Fiber Outer 1

KONSYL ORIGINAL FORMULA PSYLLIUM FIBER 
psyllium husk granule
Product Information
Product TypeHUMAN OTC DRUGItem 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 Description
1NDC:0224-1801-3530 in 1 BOX
16 g in 1 PACKET
2NDC:0224-1801-07450 g in 1 CANISTER
3NDC:0224-1801-06300 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: 08/2013
 
Konsyl Pharmaceuticals, Inc.