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.

----------

KONSYL Sugar Free Orange Flavor Psyllium Fiber

Active ingredient (in each dose)                                       
Psyllium Hydrophilic Mucilloid 3.5 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: aspartae, citric acid, FD and C Yellow No. 6 (Sunset Yellow), flavoring, maltodextrin, silicon dioxide.

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

KONSYL ORANGE SUGAR FREE PSYLLIUM FIBER   Psyllium Hydrophilic Mucilloid  Smooth Texture  Gluten Free  Helps Lower Cholesterol  NET WEIGHT 5.8g  Heart Healthy  SUPPLEMENT/LAXATIVE TAMPER-EVIDENT PACKAGE.  DO NOT USE IF OPENED OR DAMAGED

NDC 0224-1855-30    KONSYL  ORANGE FLAVOR  PSYLLIUIM FIBER  Psyllium Hydrophilic Mucilloid  Heart Healthy  Smooth Texture  Gluten Free  Helps Lower Cholesterol  Sugar Free SUPPLEMENT/LAXATIVE 30-Net Weight 5.8g Packets

NDC 0224-1855-30    KONSYL  ORANGE FLAVOR  PSYLLIUIM FIBER  Psyllium Hydrophilic Mucilloid  Heart Healthy  Smooth Texture  Gluten Free  Helps Lower Cholesterol  Sugar Free SUPPLEMENT/LAXATIVE 30-Net Weight 5.8g Packets

NDC 0224-1855-06  HEART HEALTHY   ORANGE SUGAR FREE  KONSYL 3.5grams PSYLLIUIM HYDROPHILIC MUCILLOID per Teaspoonful  NATURAL FIBER THERAPY BULK-FORMING LAXATIVE   NATURALLY SOFTENS STOOLS  HELPS LOWER CHOLESTEROL  SMOOTH TEXTURE  51 TEASPOON DOSES NET WT. 300g (10.6 OZ)  (Fill controlled by weight, not volume)  NUTRASWEET

NDC 0224-1855-07   KONSYL  ORANGE FLAVOR  PSYLLIUM FIBER  Psyllium Hydrophilic Mucilloid  Heart Healthy   Smooth Texture  Gluten Free  Helps Lower Cholesterol  Sugar Free  SUPPLEMENT/LAXATIVE  NET WEIGHT 450g (15.9 oz)  (FILL CONTROLLED BY WEIGHT NOT VOLUME)

KONSYL Sugar Free Orange Flavor Psyllium Fiber5.8g

KONSYL Sugar Free Orange Flavor Psyllium Fiber 30packA

KONSYL Sugar Free Orange Flavor Psyllium Fiber 30packB

KONSYL SUGAR FREE ORANGE FLAVOR PSYLLIUM FIBER  
psyllium husk granule
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0224-1855
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSYLLIUM HUSK (PSYLLIUM HUSK) PSYLLIUM HUSK3.5 g  in 5.8 g
Inactive Ingredients
Ingredient NameStrength
ASPARTAME 
CITRIC ACID MONOHYDRATE 
FD&C YELLOW NO. 6 
MALTODEXTRIN 
SILICON DIOXIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0224-1855-3030 in 1 BOX
15.8 g in 1 PACKET
2NDC:0224-1855-06300 g in 1 CANISTER
3NDC:0224-1855-07450 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(0224-1855)

Revised: 8/2013
 
Konsyl Pharmaceuticals, Inc.