PSYLDEX NATURAL VEGETABLE LAXATIVE- psyllium husk powder, for solution 
Contract Pharmacal Corp

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.

----------

NATURAL VEGETABLE LAXATIVE
PSYLDEX

DIETARY FIBER SUPLEMENT

Dosage Adults 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.

Supplement Facts
Serving Size 1 rounded teaspoon (7g)
Servings Per Container 48
Amount Per Serving%DV
Calories 25
Total Carbohydrates 7 g2%**
Dietary Fiber 3 g12%**
Soluble Fiber 2 g
Sugars 3 g
Iron 0.4 mg2%**
Sodium 5mg<1% **
Poyllium 30mg<1% **
Psyllium Hydrophilic Mucilloid 3.4 g
**Percent Daily Values (DV) are based on a 2,000 Calorie Diet.
†Daily Value (DV) not established.

Inactive Ingredient sucrose.

FIBER LAXATIVE

Drug Facts

Active ingredient

(in each TEASPOON)

Psyllium husk approximately 3.4 g

Purpose

Fiber laxative

Uses

  • effective in treating occasional constipation and restoring regularity.

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.

Allergy alert:

This product may cause allergic reaction in people sensitive to inhaled or ingested psyllium.

Ask a doctor before use if you have

  • a sudden change in bowel habits persisting for 2 weeks
  • abdominal pain, nausea or vomiting

Stop use and ask a doctor if

  • constipation lasts more than 7 days
  • recta bleading occurs

These may be signs of a serious condition.

Keep out of reach of children.

In case of accidental overdose, seek professional assistance or contact a Poison Control Center right away.

Directions Put one does into an empty glass. 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 warning. Stir brisldy and drink promptly. If mixture thickens, add more liquid and stir.

Adults 12 yrs. & older1 rounded TEAPOON 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.
6-11 yrs.1/2 adult dose in 8 oz of liquid, up to 3 times daily.
Under 6yrs.Consult a doctor.

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. New Users: Start with 1 dose per day; gradually increase to 3 doses per day as necessary.

Other information

  • each teaspoon contains: potassium 30 mg; sodium 5 mg
  • store at room temperature, USP
  • contains a 100% natural, therapeutic fiber

Inactive Ingredient:

sucrose

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

Manufactured by:
Contract Pharmacal Corp.
Hauppauge, NY 11788 USA
www.CPCHealth.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

28bd5af2-figure-01
PSYLDEX  NATURAL VEGETABLE LAXATIVE
psyllium husk powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10267-2688
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G) PSYLLIUM HUSK3.4 g  in 7 g
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorBROWN (Tanish-yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10267-2688-1368 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33406/22/2009
Labeler - Contract Pharmacal Corp (968334974)
Establishment
NameAddressID/FEIBusiness Operations
Contract Pharmacal Corp968334974MANUFACTURE

Revised: 2/2012
 
Contract Pharmacal Corp