SPL v6
SPL
SPL Set ID fcc9a98b-bb35-498a-93ac-666e57df438e
Route
ORAL
Published
Effective Date 2025-01-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Psyllium Husk (3.4 g)
Inactive Ingredients
Anhydrous Citric Acid Stevia Rebaudiana Leaf Glycerin

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-03-18

Description

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

Purpose

Bulk-forming laxative


Medication Information

Purpose

Bulk-forming laxative

Description

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

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.

Safety Warning

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

Active Ingredient

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

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.

Inactive Ingredients

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

Questions Or Comments?

1-866-467-2748

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


Structured Label Content

Use

effective in treating occasional constipation and restoring regularity

Purpose

Bulk-forming laxative

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.

Safety Warning

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

Active Ingredient (Active ingredient)

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

Other Information (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.

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

1-866-467-2748

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


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