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Natural Fiber Therapy Natural Laxative

Dosage form: powder, for solution
Ingredients: PSYLLIUM HUSK 3.4g in 7g
Labeler: Preferred Pharmaceuticals, Inc.
NDC Code: 68788-9558

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

BULK FORMING LAXATIVE / DIETARY FIBER SUPLEMENT

Dosage Adults 12 years & older: 1 rounded TABLESPOON 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 tablespoon (12g)

 Servings Per Container 30

 Amount Per Serving

 %DV

 Calories 45

 Total Carbohydrates 12 g

 4%**

 Dietary Fiber 3 g

 12%**

 Soluble Fiber 2 g

 †

 Sugars 9 g

 †

 Iron 0.8 mg

 4%**

 Sodium 5mg

 <1% **

 Potassium 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.

Ingredient sucrose, psyllium husk, citric acid, natural orange flavor, FD&C yellow No. 6 lake

FIBER LAXATIVE

Drug Facts

Active ingredient

(in each rounded TABLESPOON)

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 & Childrent 12 years & ovr

 1 rounded TABLESPOON 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 yrs.

 1/2 adult dose in 8 oz of liquid, up to 3 times daily.

Children under 6 yrs.

 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 tablespoon contains: potassium 30 mg; sodium 5 mg
store at room temperature, USP
protect contents from humidity
contains a 100% natural, therapeutic fiber

Inactive Ingredient:

citric acid, fd&c yellow no. 6, fd&c yellow no. 6 lake, natural orange flavor and sucrose

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

Distributed by:
MAJOR PHARMACEUTICALS
LIVONIA, MI 48150 USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68788-9558-3

Natural Fiber Therapy Orange Flavor
(Psyllium Husk)
13 oz (368g)

NATURAL FIBER THERAPY  NATURAL LAXATIVE
psyllium husk powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-9558(NDC:0904-5200)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSYLLIUM HUSK (PSYLLIUM HUSK) PSYLLIUM HUSK3.4 g  in 7 g
Inactive Ingredients
Ingredient NameStrength
SUCROSE 
ANHYDROUS CITRIC ACID 
FD&C YELLOW NO. 6 
Product Characteristics
ColorBROWN (Tanish-yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68788-9558-3368 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33411/14/2013
Labeler - Preferred Pharmaceuticals, Inc. (791119022)
Registrant - Preferred Pharmaceuticals, Inc. (791119022)
Establishment
NameAddressID/FEIOperations
Preferred Pharmaceuticals, Inc.791119022RELABEL(68788-9558)

Revised: 12/2017
 
Preferred Pharmaceuticals, Inc.

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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.

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