FDA Label for Psyllium Husk Fiber Supplement

View Indications, Usage & Precautions

Psyllium Husk Fiber Supplement Product Label

The following document was submitted to the FDA by the labeler of this product Time Cap Labs Inc. 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


Active Ingredient (In Each Capsule)



Psyllium husk approximately 0.52 g


Purpose



Bulk Forming Laxative


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 weeks

STOP 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 regularity
2 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 cholestrol
5 capsules up to 4 times per day

HEALTHY BLOOD SUGAR LEVELS**

take before each meal
5 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



  • each capsule contains: potassium 5 mg
  • capsules are sealed using a band around the middle
  • store at room temperature. Keep the container tightly closed to protect from humidity
  • contains a 100% natural, therapeutic fiber
  • tamper evident: do not use if printed inner seal under cap is broken or missing

Inactive Ingredient



Ingredients Psyllium husk, gelatin


Otc - Questions



Questions or comments? Call 1-877-290-4008


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