SUGAR FREE PSYLDEX

Dosage form: powder, for solution
Ingredients: PSYLLIUM HUSK 3.4g in 5.8g
Labeler: Contract Pharmacal Corporation
NDC Code: 10267-1936

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.

SUGAR FREE PSYLDEX

NATURAL VEGETABLE LAXATIVE
ORANGE FLAVOR
SUGAR FREE

A natural non-irritating bulk-producing dietary fiber which promotes relief of constipation.

Contains no chemical stimulants.

When recommended by a physician, is useful in the treatment of bowel disorders other than constipation.

Approximately 20 calories per dose and less than 0.004 gram of sodium.

SUGAR FREE PSYLDEX
BRAND OF PSYLLIUM HYDROPHILIC MUCILLOID

SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION.
READ ENTIRE LABEL INCLUDING WARNINGS.

DIETARY FIBER SUPLEMENT

DosageAdults 12 years & older: 1 rounded TEASPOON in 8 oz of liquid 3 times daily. Children under 12 years: Consult a doctor.

Notice Take this product with at least 8 ounces (a full glass) of liquid. Taking this product without enough liquid may cause choking. Do not take if you have difficulty swallowing. See warnings.

**Percent Daily Values (DV) are based on a 2,000 Calorie Diet.
Daily Value (DV) not established.
Supplement Facts
Serving Size 1 rounded teaspoon (5.8g)
Servings Per Container 48
Amount Per Serving                                     %DV
Calories 20
Sodium 5 mg<1%**
Total Carbohydrates 5 g2%**
Dietary Fiber 3 g12%**
Soluble Fiber 2 g
Sugars 0 g
Calcium 7 mg<1%**
Iron 1 mg4% **
Psyllium Hydrophilic Mucilloid 3.4 g

Inactive Ingredients Aspartame, + citric acid, FD&C Yellow #6 Lake, Maltodextrin, Orange Flavor and Sodium Lauryl Sulfate.

+Contains Phenylalanine 6 mg. per teaspoon

Fiber Laxative

Uses

Effective in treating occasional constipation and restoring regularity. Contains 100% natural therapeutic fiber.

Dosage

Adults 12 years & older: 1 rounded TEASPOON in 8 oz of liquid at the first sign of irregularity. Can be taken up to 3 times daily. Generally produces effect in 12-72 hours.

Children 6 to under 12 years: 1/2 adult dose in 8 oz of liquid, up to 3 times daily.

Children under 6 years: Consult a doctor.

Active ingredient:

Approximately 3.4 g of psyllium husk per dose.

Inactive Ingredients:

Aspartame, + citric acid, FD&C Yellow #6 Lake, Maltodextrin, Orange Flavor and Sodium Lauryl Sulfate.

Warnings

DO NOT USE THIS PRODUCT FOR A PERIOD LONGER THAN ONE WEEK. CONSULT A DOCTOR IF YOU HAVE RECTAL BLEEDING OR FAIL TO HAVE A BOWEL MOVEMENT AS IT MAY BE A SIGN OF A MORE SERIOUS CONDITION.

Manufactured by:
Contract Pharmacal Corp.
Hauppauge, NY 11788

NOTE SEPARATE USES

Directions Put one does into an empty glass. Fill glass with at least 8 oz of water or your favorite beverage. Stir briskly and drink promptly. If mixture thickens, add more liquid and stir.

MIX THIS PRODUCT (CHILD OR ADULT DOSE) WITH AT LEAST 8 OZ (A FULL GLASS) OF WATER OR OTHER LIQUID. TAKING THIS PRODUCT WITHOUT ENOUGH LIQUID MAY CAUSE CHOKING. SEE WARNINGS.

Laxatives, including bulk fibers, may affect how well other medicines work. If you are taking a prescription medicine by mouth, take this product at least 2 hours before or 2 hours after the prescribed medicine. As your body adjusts to increased fiber intake, you may experience changes in bowel habits or minor bloating.

Warnings Before using this product, consult a doctor if you:

  • have a sudden change in bowel habits persisting for 2 weeks
  • abdominal pain, nausea, vomiting or rectal bleeding
  • are considering use of this product as part of a cholesterol-lowering program.

Keep out of reach of children.

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. 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. May cause allergic reaction in people sensitive to inhaled or ingested psyllium.

Store at room temperature, USP.

*This product is not manufactured or distributed by Procter & Gamble, distributor of Metamucil®.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
SUGAR FREE PSYLDEX 
psyllium husks powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10267-1936
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSYLLIUM HUSK (PSYLLIUM HUSK) PSYLLIUM HUSK3.4 g  in 5.8 g
Inactive Ingredients
Ingredient NameStrength
ASPARTAME 
CITRIC ACID MONOHYDRATE 
FD&C YELLOW NO. 6 
MALTODEXTRIN 
LACTOSE 
ORANGE 
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) 
RAW SUGAR 
CARBOXYMETHYLCELLULOSE 
PROPYLENE GLYCOL ALGINATE 
BUTYLATED HYDROXYANISOLE 
COW MILK 
ORANGE JUICE 
BENZYL ALCOHOL 
Product Characteristics
ColorORANGE (pale orange) Score    
ShapeSize
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:10267-1936-6284 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33401/24/2001
Labeler - Contract Pharmacal Corporation (968334974)
Establishment
NameAddressID/FEIOperations
Contract Pharmacal Corporation968334974MANUFACTURE

Revised: 01/2012
 
Contract Pharmacal Corporation

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web5)