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Leader

Cardinal Health

Leader Natural Fiber


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each TABLESPOON)

Psyllium husk approximately 3.4 g

Purpose

Fiber laxative

Leader Uses

  • effective in treating occasional constipation and restoring 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 allergic reaction in people sensitive to inhaled or ingested psyllium.

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 if

  • constipation lasts more than 7 days
  • rectal bleeding occurs

These may be signs of a serious condition.

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.

Leader 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.

DISTRIBUTED BY: CARDINAL HEALTH

DUBLIN OH 43017

CIN 4553657

www.myleader.com

1-800-200-6313

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
Leader Smooth Texture Natural Fiber 48 Servings

Leader

Psyllium Husk POWDER

Product Information

Product Type Human otc drug label Item Code (Source) NDC:37205-666
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Psyllium Husk PSYLLIUM HUSK 3.4 g

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
FD&C YELLOW NO. 6
maltodextrin
SILICON DIOXIDE
SUCROSE

Product Characteristics

Color
BROWN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:37205-666-20 575 in 1 CANISTER

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2012-07-01


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Be sure to consult your doctor before taking any medication!
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