ULTRA ORGANIC FIBER SUGAR FREE- psyllium husk powder

Ultra Organic Fiber by

Drug Labeling and Warnings

Ultra Organic Fiber by is a Otc medication manufactured, distributed, or labeled by Raritan Pharmaceuticals Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Psyllium husk 3.4g (per each rounded teaspoon = 7g)

Purpose

Bulk-forming laxative

Use

effective in treating occasional constipation and restoring regularity

Warnings

Allergy alert:This product may cause an allergic reaction in people sensitive to inhaled or ingested psyllium.

Directions

Adults 12 Years and older (up to 3 times daily): Put 1 rounded TEASPOON into an empty glass. Mix this product with at least 8 oz (a full glass) of water.

Stir briskly to mix the fiber into the water fully and drink promptly. Taking without enough water may cause choking. Do not take this product if you have difficulty following.

As bulk-forming fibers such as Nusyllium Ultra may affect how medicines work, take this product at least 2 hours before or after taking your medicine,

You can take NuSyllium Ultra at any time of the day. Children under 12 years: Consult a doctor before use.

Stop using a NuSyllium and see a doctor if constipation lasts more than a week or if rectal bleeding occurs as these may be signs of a serious condition.

FIRST-TIME USERS

Start with one serving per day and then adjust your dose upwards as needed. Adding fiber to your diet may cause changes in your bowel habits or minor bloating.

These are normal reactions as your body adjusts to the increase fiber in your diet.

Keep Out of Reach of Children

[Enter Keep Out of Reach of Children here]

Other information

Diets low in saturated fat and cholesterol that include 7 grams of soluble fiber per day from fiber such as NuSyllium may reduce the risk of heart disease by lowering cholesterol.

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

Questions or comments?

1-866-467-2748

Inactive ingredients

Natural Citric Acid, Natural Flavors, Natural Stevia Extract, Organic Glycerin.

Principal Display Panel

NDC 68163-575-42

NuSyllium

Ultra Sugar Free Organic Fiber

7 GRAMS OF FIBER PER TEASPOON DOSE

Perfect Grind™ For Easy Mixing

• Fiber laxative for regularity
• Natural Orange Flavor

NO ARTIFICIAL INGREDIENTS

42 DOSES WEIGHT 10.7 OZ (300 GRAMS)

Fill controlled by weight, not volume

*Compared to leading Nusyllium product

Folks are Taking about the Benefits of NuSyllium Ultra Organic Natural Fiber!

• You can use NuSyllium Ultra to feel less hungry between meals.
• Maintain healthy blood sugar levels by using NuSyllium Ultra as part of your sugar free diet*. Talk to your doctor before use if you are taking medication to control your blood sugar levels.
• Organic NuSyllium is a great choice for promoting and maintain digestive health. You can use NuSyllium Ultra for occasional constipation and to help promote and maintain regularity.
• Did you know that one dose of NuSyllium Ultra contains 5 gm of soluble fiber? You can use it for lowering cholesterol and promoting heart health*.
• Talk to your doctor who will have good advice for you to use NuSyllium Ultra as part of your cholesterol –lowering program.

No Artificial Flavors, Peanut-free

No Artificial Colors, Tea Nut-free

GMO-free, Preservative-free

Gluten-free, Zero Trans Fat

Diary-free, No animal testing

Made in the U.S.A. with domestic and foreign components.

Distributed by: Lifelab Health LLC

6574 N.State Road #7 361

Coconut Creek, FL 33073

INGREDIENTS AND APPEARANCE

ULTRA ORGANIC FIBER  SUGAR FREE
psyllium husk powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68163-575
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G)	PSYLLIUM HUSK	3.4 g  in 7 g

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color	BROWN	Score
Shape		Size
Flavor	ORANGE (Orange Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68163-575-42	300 g in 1 CANISTER; Type 0: Not a Combination Product	03/18/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	03/18/2019

Labeler - Raritan Pharmaceuticals Inc (127602287)