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| Product NDC Code | 36800-558 | ||||
|---|---|---|---|---|---|
| Drug Name | Topco fiber therapy sugar free |
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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 | TOPCO ASSOCIATES LLC | ||||
| 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 TEASPOON) Psyllium husk approximately 3.4 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: Put one dose into an empty glass. Mix this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. See choking warning. Stir briskly and drink promptly. If mixture thickens, add more liquid and stir. Adults & children 12 years & older: 1 rounded TEASPOON in 8 oz. of liquid at the first sign of irregularity. Can be taken up to 3 times daily. Children 6-11 yrs : ½ adult dose in 8 oz. of liquid, up to 3 times daily Children under 6 yrs: Consult a doctor Bulk-forming fibers like psyllium husk may affect how well other medicines work. If you are taking a prescription medicine by mouth, take this product at least 2 hours before or 2 hours after the prescribed medicine. New Users: Start with 1 serving per day; gradually increase to 3 doses per day as necessary. You may initially experience changes in bowel habits or minor bloating, as your body adjusts to increased fiber intake.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: aspartame, citric acid, FD&C Yellow 6, maltodextrin, natural and artificial orange flavor, silica. Questions or comments? 1-888-423-0139
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.Uses: ▪ for relief of occasional constipation (irregularity) ▪ generally produces bowel movement in 12-72 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.Topco Fiber Therapy Sugar Free Psyllium Husk PSYLLIUM HUSK PSYLLIUM HUSK ASPARTAME ANHYDROUS CITRIC ACID FD&C Yellow No. 6 MALTODEXTRIN SILICON DIOXIDE Light Yellowish natural and artifcial
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.PRINCIPAL DISPLAY PANEL NDC 36800-558-80 COMPARE TO THE METAMUCIL ® 4 IN 1 MULTIHEALTH FIBER! ™* SUGAR FREE (NOT A LOW CALORIE FOOD) Fiber Therapy PSYLLIUM HUSK DAILY FIBER SUPPLEMENT THERAPY FOR REGULARITY • Helps lower cholesterol to promote heart health† • Promotes digestive health ** • Helps maintain healthy blood sugar levels as part of your diet ** • Orange Smooth Fiber Powder • Gluten free ORANGE FLAVOR NATURALLY AND ARTIFICIALLY FLAVORED 180 TEASPOON ‡ Doses FILL CONTROLLED BY WEIGHT, NOT VOLUME NET WT 36.8 OZ (2 LB 4.8 OZ) 1.04 kg K PAREVE QUALITY GURANTEED ‡ Serving size varies See DIRECTIONS on back panel for more information †See back for information about soluble fiber and heart disease. **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. TAMPER EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by Procter & Gamble, the distributor of Metamucil ® 4 in 1 MultiHealth Fiber!™. This product has a low glycemic index, a measure of the effect of dietary carbohydrates on blood sugar levels. This Top Care product is laboratory tested to guarantee its highest quality. You total satisfaction is guaranteed. DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007 © TOPCO RARA1217 QUESTIONS? 1-888-423-0139 [email protected] www.topcarebrand.com TopCare health Sugar Free Fiber Therapy Psyllium Husk
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
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have ▪ a sudden change in bowel habits persisting for 2 weeks ▪ abdominal pain, nausea or vomiting
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. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
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? 1-888-423-0139
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if ▪ constipation lasts more than 7 days ▪ rectal bleeding occurs These may be signs of a serious condition.
Storage and handling
Information about safe storage and handling of the drug product.Other information: ▪ each teaspoon contains: potassium 35 mg; sodium 5 mg ▪ PHENYLKETONURICS: CONTAINS PHENYLALANINE, 25 mg per teaspoon ▪ contains a therapeutic fiber ▪ store at room temperature. Keep the container tightly closed to protect from humidity
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: Choking: Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention. Allergy alert: This product may cause allergic reaction in people sensitive to inhaled or ingested psyllium. Ask a doctor before use if you have ▪ a sudden change in bowel habits persisting for 2 weeks ▪ abdominal pain, nausea or vomiting Stop use and ask a doctor if ▪ constipation lasts more than 7 days ▪ rectal bleeding occurs These may be signs of a serious condition. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
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