FDA Label for Psyllium Fiber
View Indications, Usage & Precautions
Psyllium Fiber Product Label
The following document was submitted to the FDA by the labeler of this product Time Cap Laboratories, 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.
Supplement Facts
Serving Size | 2 rounded tsp (11.6 g) | 1 rounded tsp (5.8 g) | ||
Servings Per Container | About 36 | About 72 | ||
Amount per Serving | % DV* | % DV* | ||
Calories | 30 | 15 | ||
Total Carbonate | 10g | 4%* | 5 g | 2%* |
Dietary Fiber | 6 g | 21%* | 3 g | 11%* |
Soluble Fiber | 5 g | †† | 2 g | †† |
Iron | 0.8 mg | 4% | 0.4 mg | 2% |
Sodium | 10 mg | <1% | 5 mg | <1% |
Potassium | 70 mg | 1% | 35 mg | 1% |
*Percent Daily Values (%DV) are based on a 2,000 calorie diet.
†† Daily Value (DV) not established.
Inactive Ingredient
INGREDIENTS: aspartame powder, citric acid monohydrate, colloidal silicon dioxide, FD&C yellow no. 6, maltodextrin, orange flavor, psyllium husk
Warnings
ALLERGY ALERT: This product may cause allergic reactions in people sensitive to inhaled or ingested psyllium.
NOTICE: Mix 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.
IMPORTANT INFORMATION:
PHENYLKETONURICS: CONTAINS PHENYLALANINE, 30 mg per teaspoon
Store below 86°F (30° C). Keep container tightly closed to protect from humidity.
Keep out of reach of children
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. Bulk-forming fibers like psyllium husk may affect how well medicines work. Take this product at least 2 hours before or after medicines.
BEFORE USINGthis 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.
Dosage & Administration
HOW TO TAKE THIS PRODUCT
(For adults 12 years and older)
1. Put 1-2 rounded teaspoons in empty glass.
2. Mix briskly with 8 oz or more of cool liquid.
3. Drink promptly and enjoy!
HOW MUCH TO TAKE
The psyllium husk fiber in this product helps support:
DIGESTIVE HEALTH** by promoting regularity
HEART HEALTH†† by lowering cholesterol
HEALTHY BLOOD SUGAR LEVELS** take before each meal
1 ROUNDED TEASPOONS up to 3 times per day
OR
APPETITE CONTROL** take before each meal
2 ROUNDED TEASPOONS up to 3 times per day
** THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE.
††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 2.4 grams of this soluble fiber.
Otc - Questions
Questions or comments?
Call
1-877-290-4008
Otc - Purpose
Fiber Laxative
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Indications & Usage
for relief of occasional constipation (irregularity). This product generally produces bowel movement in 12 to 72 hours.
Package Label.Principal Display Panel
* Please review the disclaimer below.