PSYLLIUM FIBER- psyllium husk powder

Psyllium Fiber by

Drug Labeling and Warnings

Psyllium Fiber by is a Other medication manufactured, distributed, or labeled by Marlex Pharmaceuticals Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Supplement Facts

Serving Size: 1 rounded Tbsp. (12 g)

Servings per container: 30

Amount per serving % Daily Value

Calories 45

Total Carbohydrate 12 g 4%*

Dietary Fiber 3 g 11%*

Soluble fiber 2 g ϯ

Total sugar 8 g ϯ

Includes 8 g Added Sugars 16%*

Iron 0.7 mg 4%*

Sodium 5 mg < 1%*

Potassium 35 mg < 1%*

*Percent Daily Values are based on a 2,000 calorie Diet

ϯ Daily Value not established.

Diets low in saturated fat and cholesterol that include 7 grams of soluble fiber per day from Psyllium seed husk, may reduce the risk of heart disease by lowering cholesterol levels. One serving provides 2.4 grams of this soluble fiber. Consult a doctor if you are considering the Use of the product as part of a cholesterol-lowering program.

Directions:

Adults 12 years & over 1: 1 rounded tablespoon (Tbsp = tablespoon), 3 times daily

Children under 12 years: Consult a doctor. Put one serving into an empty glass and fill glass with 8 oz of water. Stir briskly and drink promptly. If mixture thickens, add more water and stir. Take up to 3 times daily

New Users: Start with 1 serving per day; gradually increase up to 3 servings per day as necessary. You may initially experience changes in bowel habits or minor bloating, as your body adjusts to increased fiber intake.

NOTICE: Mix this product with at least 8 oz (a full glass) of liquid. Taking this product without enough liquid may cause choking. Do not take if you have difficulty swallowing.

Allergy alert: May cause allergic reaction in people sensitive to ingested or inhaled psyllium. Ask a doctor before use if you have abdominal pain, nausea or vomiting or experience a sudden change in bowel habits persisting for 2 weeks.

Stop use and ask a doctor if constipation lasts more than 7 days or rectal bleeding occurs. These may be signs of a serious condition.

Bulk-forming fibers like psyllium husk 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.

Keep out of reach of children.

Do not use if printed seal under cap is missing or broken.

Store at 20°C - 25 C (68°F - 77°F)

WARNING:

Consuming this product can expose you to chemicals including lead, which is known to the State of California to cause birth defects or other reproductive harm. For more information, go to www.P65Warnings.ca.gov/food.

Ingredients: Sucrose, Psyllium Husk, Citric Acid, Natural and Artificial Orange Flavor, Silicon Dioxide, FD&C Yellow #6.

Manufactured for and Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Rev. 10/20 GP

PRINCIPAL DISPLAY PANEL

NDC: 10135-0714-92
Marlex Pharmaceuticals
Psyllium Fiber Powder
Orange Flavor      
368 g (13 oz)

Revised: 10/2020

Document Id: 702fbfb7-cb08-4fda-a344-9c913f35bed1

58476-3

Set id: afa81aad-6ada-4275-9946-e9fceb62bfe9

Version: 1

Effective Time: 20201006

Marlex Pharmaceuticals, Inc.

INGREDIENTS AND APPEARANCE

PSYLLIUM FIBER 
psyllium husk powder

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:10135-714
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G)	PSYLLIUM HUSK	2.4 g  in 12 g

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:10135-714-92	368 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		10/01/2020

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
flavor

Labeler - Marlex Pharmaceuticals Inc (782540215)