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| Product NDC Code | 0536-4306 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Fiber lax |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | ORAL | ||||||||
| Dosage Form | TABLET, FILM COATED | ||||||||
| RxCUI drug identifier | 308934 | ||||||||
| Application Number | M007 | ||||||||
| Labeler Name | Rugby Laboratories | ||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Overdosage of Fiber Lax
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Active ingredient
A list of the active, medicinal ingredients in the drug product.Drug Facts Active ingredient (in each tablet) Calcium polycarbophil 625 mg (equivalent to polycarbophil 500 mg)
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 (child or adult dose) with a full glass of water (8oz.) or other fluid. Taking this product without enough liquid may cause choking. See choking warning adults and children 12 years and over 2 tablets, 1 to 4 times per day children under 12 years ask a doctor
| adults and children 12 years and over | 2 tablets, 1 to 4 times per day |
| children under 12 years | ask a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Caramel, crospovidone, hypromellose, magnesium silicate, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, silica, sodium lauryl sulfate and stearic acid
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 relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours
Purpose
Information about the drug product’s indications for use.Purpose Purpose Bulk-forming laxative
Spl product data elements
Usually a list of ingredients in a drug product.Fiber Lax Calcium Polycarbophil CARAMEL CROSPOVIDONE HYPROMELLOSES TALC MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE LIGHT MINERAL OIL POLYETHYLENE GLYCOL 400 SILICON DIOXIDE SODIUM LAURYL SULFATE STEARIC ACID CALCIUM POLYCARBOPHIL POLYCARBOPHIL Off-white CPC;339
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.Rugby NDC 0536-4306-05 Comapare to Active ingredient in FiberCon* Fiber-Lax Calcium Polycarbophil 625 mg Bulk-Forming Laxative Safe and Effective Relief of Occasional Constipation Promotes Regularity 500 Tablets Rugby 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.*This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, owner of the registered trademark FiberCon® WARNING: This product can expose you to chemicals including lead, which is known to the State of California to cause cancer and birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov. Distributed by: Rugby Laboratories Indianapolis, IN 46268 www.majorpharmaceuticals.com (800) 616-2471
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 abdominal pain, nausea, or vomiting a sudden change in bowel habits that persists over a period of 2 weeks
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if you are taking any other drug. Take Fiber-Lax two or more hours before or after other drugs. Laxatives may affect how other drugs work.
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information • each tablet contains : calcium 140 mg • do not use if printed seal under cap is torn or missing • store in a dry place at 15° – 30°C (59° – 86°F). • protect contents from moisture
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? (800) 231-4670
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 • you fail to have a bowel movement after use or have rectal bleeding. These could be signs of a serious condition.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product • do not use for more than 7 days unless directed by a doctor • do not take more than 8 tablets in a 24-hour period unless directed by a doctor
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.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. Ask a doctor before use if you have abdominal pain, nausea, or vomiting a sudden change in bowel habits that persists over a period of 2 weeks Ask a doctor or pharmacist before use if you are taking any other drug. Take Fiber-Lax two or more hours before or after other drugs. Laxatives may affect how other drugs work. When using this product • do not use for more than 7 days unless directed by a doctor • do not take more than 8 tablets in a 24-hour period unless directed by a doctor Stop use and ask a doctor if • you fail to have a bowel movement after use or have rectal bleeding. These could 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 (1-800-222-1222) right away.
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