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| Product NDC Code | 49483-739 | ||||
|---|---|---|---|---|---|
| Drug Name | Psyllium fiber |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | POWDER | ||||
| RxCUI drug identifier | 824586 | ||||
| Application Number | M007 | ||||
| Labeler Name | TIME CAP LABORATORIES, INC. | ||||
| Packages |
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Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INGREDIENTS: aspartame powder, citric acid monohydrate, colloidal silicon dioxide, FD&C yellow no. 6, maltodextrin, orange flavor, psyllium husk
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.for relief of occasional constipation (irregularity). This product generally produces bowel movement in 12 to 72 hours.
Purpose
Information about the drug product’s indications for use.Fiber Laxative
Spl product data elements
Usually a list of ingredients in a drug product.Psyllium Fiber Psyllium Husk PSYLLIUM HUSK PSYLLIUM HUSK CITRIC ACID MONOHYDRATE ASPARTAME MALTODEXTRIN SILICON DIOXIDE FD&C YELLOW NO. 6 White to light brown
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.psyllium-husk-powder-15oz-label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.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.
| 2 rounded tsp (11.6 g) | 1 rounded tsp (5.8 g) | |||
| About 36 | About 72 | |||
| 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% |
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? Call 1-877-290-4008
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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 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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API