SPL v6
SPL
SPL Set ID c30129ac-4517-48b5-aafd-e65ec54b340e
Route
ORAL
Published
Effective Date 2019-08-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Psyllium Husk (3.4 g)
Inactive Ingredients
Anhydrous Citric Acid Raw Sugar Glycerin

Identifiers & Packaging

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

Description

Psyllium Hydrophilic Mucilloid 3.4g

Purpose

Fiber therapy for regularity


Medication Information

Purpose

Fiber therapy for regularity

Description

Psyllium Hydrophilic Mucilloid 3.4g

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.

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 thickness, add more liquid and stir.

Adults 12 years & older: 1 rounded TABLESPOON in 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 yrs: 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 2 hours after the prescribed medicine. As your body adjusts to increase 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.

Allergy Alert:

This product may cause allergic reaction in people sensitive to inhaled or ingested psyllium.

Other Information
  • each tablespoon 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.

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

Inactive Ingredients

Natural citric acid, natural flavors, Organic Brown Cane Sugar, Organic Vegetable Glycerin.

Questions Or Comments?

1-866-467-2748

Principal Display Panel

NDC 68163-571-72

NuSyllium

Natural Orange Flavor

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 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*.

No Artificial Flavors, Peanut-free

No Artificial Colors, Tree Nut-free

GMO-free, Preservative-free

Gluten-free, Zero Trans Fat

Diary-free

NET WT 30.5 OZ (864 g) 72 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

Stop Use and Ask A Doctor
  • constipation lasts more than 7 days
  • rectal bleeding occurs

These may be sings of a serious condition

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Ask A Doctor Before Use If You Have
  • a sudden change in bowel habits persisting for 2 weeks.
  • abdominal pain, nausea or vomiting
Active Ingredient (in Each Tablespoon)

Psyllium Hydrophilic Mucilloid 3.4g


Structured Label Content

Use

for relief of occasional constipation (regularity)

Purpose

Fiber therapy for 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.

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 thickness, add more liquid and stir.

Adults 12 years & older: 1 rounded TABLESPOON in 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 yrs: 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 2 hours after the prescribed medicine. As your body adjusts to increase 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.

Allergy Alert: (Allergy alert:)

This product may cause allergic reaction in people sensitive to inhaled or ingested psyllium.

Other Information (Other information)
  • each tablespoon 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.

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

Inactive Ingredients (Inactive ingredients)

Natural citric acid, natural flavors, Organic Brown Cane Sugar, Organic Vegetable Glycerin.

Questions Or Comments? (Questions or comments?)

1-866-467-2748

Principal Display Panel

NDC 68163-571-72

NuSyllium

Natural Orange Flavor

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 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*.

No Artificial Flavors, Peanut-free

No Artificial Colors, Tree Nut-free

GMO-free, Preservative-free

Gluten-free, Zero Trans Fat

Diary-free

NET WT 30.5 OZ (864 g) 72 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

Stop Use and Ask A Doctor (Stop use and ask a doctor)
  • constipation lasts more than 7 days
  • rectal bleeding occurs

These may be sings of a serious condition

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • a sudden change in bowel habits persisting for 2 weeks.
  • abdominal pain, nausea or vomiting
Active Ingredient (in Each Tablespoon) (Active ingredient (in each TABLESPOON))

Psyllium Hydrophilic Mucilloid 3.4g


Advanced Ingredient Data


Raw Label Data

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