Ultra Organic Fiber Powder
FDA Label NDC 68163-575

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Raritan Pharmaceuticals Inc for the product Ultra Organic Fiber (NDC 68163-575). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, directions, keep out of reach of children, other information, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

* Please review the disclaimer below.