Label: LEADER NATURAL FIBER- psyllium husk powder
- NDC Code(s): 37205-667-10
- 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.
Updated July 1, 2012
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each TEASPOON)
Psyllium husk approximately 3.4 gClose
- effective in treating occasional constipation and restoring regularity
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.
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.
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.Close
- 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.Close
- SPL UNCLASSIFIED SECTION
DISTRIBUTED BY: CARDINAL HEALTH
DUBLIN OH 43017
- PRINCIPAL DISPLAY PANEL
LEADER® Natural Fiber
Compare to Metamucil® MultiHealth Fiber
Fiber Laxative/Dietary supplement
100% Natural Psyllium Fiber
Orange Flavored Powder
Not a low calorie product
fill controlled by weight not volume
NET WT 10 OZ (283 g)
Leader Smooth Texture Sugar Free Natural Fiber 48 Servings
- INGREDIENTS AND APPEARANCE
LEADER NATURAL FIBER
psyllium husk powder
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-667 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 aspartame (UNII: Z0H242BBR1) citric acid monohydrate (UNII: 2968PHW8QP) FD&C Yellow No. 6 (UNII: H77VEI93A8) maltodextrin (UNII: 7CVR7L4A2D) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 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:37205-667-10 283 g in 1 CANISTER 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)