Label: PSYLLIUM HUSK FIBER SUPPLEMENT- psyllium husk capsule
- NDC Code(s): 49483-145-20, 49483-145-40
- Packager: TIME CAP LABS INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 10, 2024
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
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Supplements Facts
Serving Size 5 Capsules Servings per container 40 (For 200 count) 80 (For 400 count) Amount per serving % DV* Calories 5 Total Carb 2 g <1%* Dietary Fiber 2 g 7%* Soluble Fiber 2 g †† Protein less than 1 g Iron 0.4 mg 2% Potassium 25 mg 1% *Percent Daily Values (%DV) are based on a 2,000 calorie diet.
††Daily Value (DV) not established.
- Active ingredient (in each capsule)
- Purpose
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Warnings
ALLERGY ALERT: This product may cause allergic reactions in people sensitive to inhaled or ingested psyllium.
BEFORE USING this dietary supplement - ask your doctor if you
are considering using this product as part of a cholesterol lowering program
are using medication to control your blood sugar levels
have recently experienced abdominal pain, nausea, vomiting or a sudden change in bowel habits persisting for two weeksSTOP USING this dietary supplement and ask a doctor if constipation lasts more than 7 days or rectal bleeding occurs. These may be signs of a serious condition.
Bulk-forming fibers like psyllium husk may affect how well medicines work. Take this product at least 2 hours before or after medicines
IMPORTANT INFORMATION
To open bottle, push down and turn
Store in a cool and dry place at temperature below 25°C. Keep container tightly closed to protect from humidity.
Keep out of reach of children -
Directions
For adults 12 years and older HELPS SUPPORT: DIGESTIVE HEALTH**
by promoting regularity2 to 5 capsules up to 4 times per day Swallow 1 capsule at a time and take in an upright position HEART HEALTH††
By lowering cholestrol5 capsules up to 4 times per day HEALTHY BLOOD SUGAR LEVELS**
take before each meal5 capsules 4 times per day ††Diets low in saturated fat and cholesterol that include 7 grams of soluble fiber per day from psyllium husk, as in this product, may reduce the risk of heart disease by lowering cholesterol. One serving of this product has 1.8 grams of this soluble fiber.
** THESE STATEMENTS HAVE NOT BEEN EVAULATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE.
NEW USERS: Start with one serving per day; gradually increase to desired daily intake. You may experience changes in bowel habits / minor bloating, as your body adjusts to increased fiber intake.
NOTICE: Take this product with at least 8 oz (a full glass) of liquid. Taking without enough liquid may cause choking. Do not take if you have difficulty swallowing
- Other information
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PSYLLIUM HUSK FIBER SUPPLEMENT
psyllium husk capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49483-145 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PSYLLIUM HUSK (UNII: 0SHO53407G) (PSYLLIUM HUSK - UNII:0SHO53407G) PSYLLIUM HUSK 0.52 g Inactive Ingredients Ingredient Name Strength GELATIN, UNSPECIFIED (UNII: 2G86QN327L) Product Characteristics Color white (Clear Body with clear cap filled with pale buff to brown granular powder) Score no score Shape CAPSULE Size 21mm Flavor Imprint Code TCL145 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49483-145-20 200 in 1 BOTTLE; Type 0: Not a Combination Product 04/05/2024 2 NDC:49483-145-40 400 in 1 BOTTLE; Type 0: Not a Combination Product 04/05/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M007 04/05/2024 Labeler - TIME CAP LABS INC (037052099) Registrant - TIME CAP LABS INC (037052099) Establishment Name Address ID/FEI Business Operations TIME CAP LABS INC 037052099 manufacture(49483-145)
