Your browser does not support JavaScript! LEADER NATURAL FIBER (PSYLLIUM HUSK) POWDER [CARDINAL HEALTH]
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LEADER NATURAL FIBER (psyllium husk) powder
[Cardinal Health]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

Drug Facts

Active ingredient (in each TEASPOON)

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 TEASPOON 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
  • PHENYLKETONURICS: CONTAINS PHENYLALANINE, 25 mg per teaspoon
  • store at room temperature tightly closed to protect from humidity
  • contains a 100% natural, therapeutic fiber

Inactive ingredients

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

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

Sugar Free

Natural Fiber

Fiber Laxative/Dietary supplement

100% Natural Psyllium Fiber

Fiber Supplement

Orange Flavored Powder

Not a low calorie product

Relieves Constipation

Restores Regularity

fill controlled by weight not volume

NET WT 10 OZ (283 g)

48 SERVINGS

Leader Smooth Texture Sugar Free Natural Fiber 48 Servings

Leader Smooth Texture Sugar Free Natural Fiber 48 Servings

LEADER  NATURAL FIBER
psyllium husk powder
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:37205-667
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Psyllium Husk (Psyllium Husk) Psyllium Husk3.4 g  in 5.8 g
Inactive Ingredients
Ingredient NameStrength
aspartame 
citric acid monohydrate 
FD&C Yellow No. 6 
maltodextrin 
SILICON DIOXIDE 
Product Characteristics
ColorBROWNScore    
ShapeSize
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-667-10283 g in 1 CANISTER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33407/01/2012
Labeler - Cardinal Health (097537435)

Revised: 7/2012
 
Cardinal Health

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