FDA Label for Natural Orange Flavor Organic Natural Fiber

View Indications, Usage & Precautions

Natural Orange Flavor Organic Natural Fiber Product Label

The following document was submitted to the FDA by the labeler of this product Raritan Pharmaceuticals Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient (In Each Tablespoon)



Psyllium Hydrophilic Mucilloid 3.4g


Purpose



Fiber therapy for regularity


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.


Ask A Doctor Before Use If You Have



  • ▪a sudden change in bowel habits persisting for 2 weeks.
  • ▪abdominal pain, nausea or vomiting

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.


Directions:



Put one dose into an empty glass. Mix this product (child or adult dose) with at least 8 oz (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.


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


Questions Or Comments?



1-866-467-2748


Inactive Ingredients



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


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


* Please review the disclaimer below.