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| Product NDC Code | 68163-119 | ||||
|---|---|---|---|---|---|
| Drug Name | Fiber laxative |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | CAPSULE | ||||
| RxCUI drug identifier | 581417 | ||||
| Application Number | part334 | ||||
| Labeler Name | Raritan Pharmaceuticals 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 • Take this product 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. • Adults 12 years and older: 5 capsules with at least 8 ounces. of liquid (swallow 1 capsule at a time) at the first sign of irregularity. Can be taken up to 3 times daily. Generally produces effect in 12-72 hours • children 12 years and under: Ask a doctor • Laxatives, including bulk fibers, may affect how well other medicines work. If you are taking a prescription medication by mouth, take this product at least 2 hours before or 2 hours after the prescribed medicine. • As your body adjusts to increased fiber intake, you may experience changes in bowel habits or minor bloating.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients caramel color, edible ink, gelatin, polysorbate 80
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 • effective in treating occasional constipation and restoring regularity
Purpose
Information about the drug product’s indications for use.Purpose Fiber laxative
Spl product data elements
Usually a list of ingredients in a drug product.fiber laxative Psyllium Husk Psyllium Husk Psyllium Husk CARAMEL GELATIN, UNSPECIFIED POLYSORBATE 80 RP119
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 - 25 Capsules Label NDC 68163-119-25 Compare to the active ingredient in Metamucil ® Capsules 3 in 1 MultiHealth Fiber!™* 100% Natural Psyllium Husk Fiber Capsules Fiber Laxative/Dietary Supplement • Helps maintain healthy blood sugar levels as part of your diet** • Helps lower cholesterol to promote heart health† • Promotes digestive health** • Gluten free (may contain trace amounts less than 20 ppm). If you have specific dietary needs, you should consult your doctor before consuming this product. †See back for information about soluble fiber and heart disease 25 Capsules Mfg. by: Raritan Pharmaceuticals 8 Joanna Court East Brunswick, NJ 08816 *This product is not manufactured or distributed by Procter & Gamble, the distributor of Metamucil® Capsules 3 in1 MultiHealth Fiber!™. DRx Choice Fiber Capsules 25 Counts
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
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.
Storage and handling
Information about safe storage and handling of the drug product.Other information • each capsule contains: potassium 5 mg • store at room temperature. Keep tightly closed to protect from humidity • contains a 100% natural, therapeutic fiber WARNING: Consuming this product can expose you to chemicals including lead, which is known to the State of California to cause cancer. For more information, go to www.P65Warnings.ca.gov.
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