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| Product NDC Code | 49483-145 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Psyllium husk fiber supplement |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | CAPSULE | ||||||
| RxCUI drug identifier | 581417 | ||||||
| Application Number | M007 | ||||||
| Labeler Name | TIME CAP LABS INC | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each capsule) Psyllium husk approximately 0.52 g
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.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
| 2 to 5 capsules up to 4 times per day | Swallow 1 capsule at a time and take in an upright position | |
| 5 capsules up to 4 times per day | ||
| 5 capsules 4 times per day |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Ingredients Psyllium husk, gelatin Questions or comments? Call 1-877-290-4008
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.effective in treating occasional constipation and restoring regularity This product generally produces bowel movement in 12 to 72 hours.
Purpose
Information about the drug product’s indications for use.Purpose Bulk Forming Laxative
Spl product data elements
Usually a list of ingredients in a drug product.Psyllium Husk Fiber Supplement Psyllium Husk GELATIN, UNSPECIFIED PSYLLIUM HUSK PSYLLIUM HUSK Clear Body with clear cap filled with pale buff to brown granular powder TCL145
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-capsules-400-label psyllium-husk-capsules-200-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.Drug Facts
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.
| 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% |
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
Storage and handling
Information about safe storage and handling of the drug product.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
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.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
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