FDA Label for Leader Natural Fiber

View Indications, Usage & Precautions

Leader Natural Fiber Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health. 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.

Other



Drug Facts

DISTRIBUTED BY: CARDINAL HEALTH

DUBLIN OH 43017

CIN 4553657

www.myleader.com

1-800-200-6313


Active Ingredient (In Each Tablespoon)



Psyllium husk approximately 3.4 g


Purpose



Fiber laxative


Uses



  • effective in treating occasional constipation and restoring regularity

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 allergic reaction in people sensitive to inhaled or ingested psyllium.


Otc - Ask Doctor



Ask a doctor before use if you have

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

Otc - Stop Use



Stop use and ask a doctor if

  • constipation lasts more than 7 days
  • rectal bleeding occurs
  • These may be signs of a serious condition.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. In case of overdose, get medical help or contact a doctor or a Poison Control Center right away.


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 and stir.

Adults 12 yrs. & 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.
6 – 11 yrs:½ adult dose in 8 oz of liquid, up to 3 times daily
Under 6 yrs:
Consult a doctor

Laxatives, including bulk fibers, 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 increased fiber intake, you may experience changes in bowel habits or minor bloating.


New Users



Start with 1 dose per day; gradually increase to 3 doses per day as necessary.


Other Information



  • each teaspoon contains: potassium 30 mg; sodium 5 mg
  • store at room temperature tightly closed to protect from humidity
  • contains a 100% natural, therapeutic fiber

Inactive Ingredients



citric acid, FD&C yellow 6, natural and artificial orange flavor, silica, sucrose.


Principal Display Panel



LEADER® Natural Fiber

 Compare to Metamucil® MultiHealth Fiber

Smooth Texture

Natural Fiber

Fiber Laxative/Dietary supplement

100% Natural Psyllium Fiber

Fiber Supplement

Orange Flavored Powder

Relieves Constipation

Restores Regularity

fill controlled by weight not volume

NET WT 20.3 OZ (575 g)

48 SERVINGS

Leader Smooth Texture Natural Fiber 48 Servings

* Please review the disclaimer below.