FDA Label for Leader Fiber
View Indications, Usage & Precautions
Leader 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.
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Drug Facts
Distributed By: Cardinal Health
Dublin OH 43017
Active Ingredient (In Each Capsule)
Psyllium husk approximately 0.52 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.
Ask a doctor before use if you have
- a sudden change in bowel habits persisting for 2 weeks
- abdominal pain, nausea or vomiting
- constipation lasts more than 7 days
- rectal bleeding occurs
Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.
Stop use and ask a doctor if
These may be signs of a serious condition.
Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- take at the first sign of irregularity
- take 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.
- adults and children 12 years of age and over: take 5 capsules with at least 8 oz. of liquid. Swallow capsules one at a time. May repeat dose up to 3 times a day.
- children 12 years and under: ask a doctor
Other Information
- do not use if printed inner seal is torn or missing
- store at room temperature tightly closed to protect from humidity
- contains a 100% natural, therapeutic fiber
- each capsule contains potassium 5 mg
Inactive Ingredients
blue 1, caramel color, gelatin, polysorbate 80, shellac, sodium lauryl sulfate, titanium dioxide.
Principal Display Panel - 100 Capsules Label
NDC 37205-372-78
Leader Fiber Capsules
100% Natural Psyllium Fiber Laxative
Relieves Constipation/
Restores regularity
100 CAPSULES
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