KONSYL ORANGE FLAVOR PSYLLIUM FIBER - ORIGINAL TEXTURE - 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 3.4 g

Purpose
Bulk-forming laxative

Use: For relief of occasional constipation (irregularity). Generally produces bowel movement in 12-72 hours. Natural bulk producing fiber encourages normal elimination without chemical stimulants.

Warnings
Allergy alert: Inhaled or ingested psyllium powder may cause an allergic reaction in people sensitive to 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.
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.

When using this product do not take for a period longer than 1 week, unless directed by a doctor

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 liquid may cause choking. See choking warnings.

adults and children 12 years and over
1 rounded tablespoonful(11g)
mixed in 8 oz of liquid, 1-3 times
daily, at the first sign of irregularity.
children 6 to under 12 years
1/2 the adult dose in 8 oz of liquid,
up to 3 times daily.
children under 6 years
Consult a doctor.

Other information
- each 11 g dose contains: Calcium 6mg, Potassium 31 mg, Sodium 3 mg
- note to diabetics: this product contains sugar (sucrose)
- store below 30°C (86°F)
- keep tightly closed to protect from humidity
- tamper-evident bottle mouth sealed for your protection
- do not use if imprinted inner seal is broken or missing
- maximum daily dose (3 tablespoonfuls) is very low sodium
- each dose provides 3 grams total dietary fiber
- each dose contains 35 calories

Inactive Ingredients: sucrose, citric acid, FD and C Yellow No. 6 (Sunset Yellow), flavoring.

Questions? Call Konsyl Pharmaceuticals, Inc. at 1-800-356-6795 8:30 a.m. to 5 p.m. ET.

Diets low in saturated fat and cholesterol that include 7 grams of soluble fiber per day from psyllium husk may reduce the risk of Coronary Heart Disease (CHD) by lowering cholesterol. ONE ADULT DOSE OF THIS PRODUCT CONTAINS 2 GRAMS OF THIS SOLUBLE FIBER = 3.4 GRAMS OF PSYLLIUM. Manufactured in U.S.A. Konsyl Pharmaceuticals, INc. Easton, MD 21601  www.konsyl.com  Konsyl Pharmaceuticals, Inc. 34707 0810

NDC 0224-1841-03  KONSYL ORANGE FLAVOR PSYLLIUM FIBER  Psyllium Hydrophilic Mucilloid  Heart Healthy  Original Texture  Gluten Free Helps Lower Cholesterol  Naturally Sweetened SUPPLEMENT / LAXATIVE  NET WEIGHT 397g (14oz) (FILL CONTROLLED BY WEIGHT NOT VOLUME)

KonsylOrange

KONSYL ORANGE FLAVOR PSYLLIUM FIBER - ORIGINAL TEXTURE 
psyllium husk granule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0224-1841
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSYLLIUM HUSK (PSYLLIUM HUSK) PSYLLIUM HUSK3.4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SUCROSE 
CITRIC ACID MONOHYDRATE 
FD&C YELLOW NO. 6 
Packaging
#Item CodePackage Description
1NDC:0224-1841-03397 g in 1 CANISTER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33403/31/2011
Labeler - Konsyl Pharmaceuticals, Inc. (102463866)
Establishment
NameAddressID/FEIBusiness Operations
Konsyl Pharmaceuticals, Inc. 102463866manufacture

Revised: 03/2011
 
Konsyl Pharmaceuticals, Inc.