LEADER NATURAL FIBER- psyllium husk powder

Leader by

Drug Labeling and Warnings

Leader by is a Otc medication manufactured, distributed, or labeled by Cardinal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each TABLESPOON)

Psyllium husk approximately 3.4 g

Purpose

Fiber laxative

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.

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.

SPL UNCLASSIFIED SECTION

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 Smooth Texture Natural Fiber 48 Servings

INGREDIENTS AND APPEARANCE

LEADER  NATURAL FIBER
psyllium husk powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-666
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Psyllium Husk (UNII: 0SHO53407G) (Psyllium Husk - UNII:0SHO53407G)	Psyllium Husk	3.4 g  in 5.8 g

Inactive Ingredients
Ingredient Name	Strength
citric acid monohydrate (UNII: 2968PHW8QP)
FD&C Yellow No. 6 (UNII: H77VEI93A8)
maltodextrin (UNII: 7CVR7L4A2D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	BROWN	Score
Shape		Size
Flavor	ORANGE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-666-20	575 g in 1 CANISTER; Type 0: Not a Combination Product	07/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	07/01/2012

Labeler - Cardinal Health (097537435)