SPL v6
SPL
SPL Set ID 04e2cb67-b092-47ee-9463-cf30ab2fb2a5
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
Raw Sugar Glycerin

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-03-20
Description

Serving Size 1 rounded teaspoon ( 7g) Servings per Container About 85 Amount Per Serving %DV* Calories 25 Total Carbohydrate 7 g 3% Dietary Fiber 3g 11% Soluble Fiber 2g † Total Sugars 4g †   Includes Added Sugars 4g 8% Iron 0.4mg 2% Sodium 5mg <1% Potassium 30 mg 1% *Percent Daily Values (%DV) are based on a 2000 calorie diet, † Daily Value (DV) not established

Purpose

Bulk-forming laxative

Medication Information

Purpose

Bulk-forming laxative

Description

Serving Size 1 rounded teaspoon ( 7g) Servings per Container About 85 Amount Per Serving %DV* Calories 25 Total Carbohydrate 7 g 3% Dietary Fiber 3g 11% Soluble Fiber 2g † Total Sugars 4g †   Includes Added Sugars 4g 8% Iron 0.4mg 2% Sodium 5mg <1% Potassium 30 mg 1% *Percent Daily Values (%DV) are based on a 2000 calorie diet, † Daily Value (DV) not established

Use

For relief of occasional constipation (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 an allergic reaction in people sensitive to inhaled or ingested psyllium.

Directions

Put one dose 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 briskly and drink promptly.

If mixture thickens, add more liquid.

Adults 12 Years and older: 1 rounded TEASPOON into an 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 under 12 years: Consult a doctor before use.

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 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 serving per day; gradually increase to desired daily intake. You may initially experience changes in bowel habits or minor bloating as your body adjusts to increased fiber intake.

Safety Warning

TAMPER-EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

Supplement Facts

Serving Size

1 rounded teaspoon ( 7g)

Servings per Container

About 85

Amount Per Serving

%DV*

Calories

25

Total Carbohydrate

7 g

3%

Dietary Fiber

3g

11%

Soluble Fiber

2g

†

Total Sugars

4g

†
  •  
    Includes Added Sugars 4g 8%

Iron

0.4mg

2%

Sodium

5mg

<1%

Potassium

30 mg

1%

*Percent Daily Values (%DV) are based on a 2000 calorie diet,

† Daily Value (DV) not established

Other Information
  • ▪
    each teaspoon contains: potassium 35 mg; sodium 5 mg
  • ▪
    store at room temperature tightly closed to protect from humidity
  • ▪
    do not use if printed seal under cap is torn or missing
  • ▪
    contains a 100% natural, therapeutic fiber

‡ 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.

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

Inactive Ingredients

Organic Brown Cane Sugar, Organic Vegetable Glycerin.

Questions Or Comments?

1-866-467-2748

Principal Display Panel

NDC 68163-570-85

NuSyllium

Unflavored Organic Natural Fiber

100% Organic Certified Psyllium

Perfect Grind For Easy Mixing™

USDA ORGANIC

NO ARTIFICIAL INGREDIENTS

100% Natural Fiber Supplement

Fiber Laxative for Regularity

Made with 100% Organic Brown Cane Sugar

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

  • •
    You can use NuSyllium 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 2 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, Tree Nut-free

GMO-free, Preservative-free

Gluten-free, Zero Trans Fat

Diary-free, No animal testing

NET WT 21 OZ (595 g) 85 DOSES

Fill controlled by weight, not volume

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, No animal testing

Structured Label Content

Use

For relief of occasional constipation (regularity)

Purpose

Bulk-forming laxative

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 an allergic reaction in people sensitive to inhaled or ingested psyllium.

Directions

Put one dose 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 briskly and drink promptly.

If mixture thickens, add more liquid.

Adults 12 Years and older: 1 rounded TEASPOON into an 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 under 12 years: Consult a doctor before use.

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 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 serving per day; gradually increase to desired daily intake. You may initially experience changes in bowel habits or minor bloating as your body adjusts to increased fiber intake.

Safety Warning

TAMPER-EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

Supplement Facts

Serving Size

1 rounded teaspoon ( 7g)

Servings per Container

About 85

Amount Per Serving

%DV*

Calories

25

Total Carbohydrate

7 g

3%

Dietary Fiber

3g

11%

Soluble Fiber

2g

†

Total Sugars

4g

†
  •  
    Includes Added Sugars 4g 8%

Iron

0.4mg

2%

Sodium

5mg

<1%

Potassium

30 mg

1%

*Percent Daily Values (%DV) are based on a 2000 calorie diet,

† Daily Value (DV) not established

Other Information (Other information)
  • ▪
    each teaspoon contains: potassium 35 mg; sodium 5 mg
  • ▪
    store at room temperature tightly closed to protect from humidity
  • ▪
    do not use if printed seal under cap is torn or missing
  • ▪
    contains a 100% natural, therapeutic fiber

‡ 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.

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

Inactive Ingredients (Inactive ingredients)

Organic Brown Cane Sugar, Organic Vegetable Glycerin.

Questions Or Comments? (Questions or comments?)

1-866-467-2748

Principal Display Panel

NDC 68163-570-85

NuSyllium

Unflavored Organic Natural Fiber

100% Organic Certified Psyllium

Perfect Grind For Easy Mixing™

USDA ORGANIC

NO ARTIFICIAL INGREDIENTS

100% Natural Fiber Supplement

Fiber Laxative for Regularity

Made with 100% Organic Brown Cane Sugar

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

  • •
    You can use NuSyllium 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 2 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, Tree Nut-free

GMO-free, Preservative-free

Gluten-free, Zero Trans Fat

Diary-free, No animal testing

NET WT 21 OZ (595 g) 85 DOSES

Fill controlled by weight, not volume

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, No animal testing

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:05:27.021802 · Updated: 2026-03-14T23:07:17.257844