Label: LEADER NATURAL FIBER- psyllium husk powder
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Contains inactivated NDC Code(s)
NDC Code(s): 37205-666-20 - Packager: Cardinal Health
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: 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 Information
Updated February 4, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each TABLESPOON)
- Purpose
- Uses
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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
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- a sudden change in bowel habits persisting for 2 weeks
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- abdominal pain, nausea or vomiting
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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.
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL
LEADER® Natural Fiber
Compare to Metamucil® MultiHealth FiberSmooth 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
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INGREDIENTS AND APPEARANCE
LEADER NATURAL FIBER
psyllium husk powderProduct 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)
