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| Product NDC Code | 55289-949 | ||||
|---|---|---|---|---|---|
| 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 | PD-Rx Pharmaceuticals, Inc. | ||||
| 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 right away.
Active ingredient
A list of the active, medicinal ingredients in the drug product.Drug Facts Active ingredient (in each captab) Calcium polycarbophil 625 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 Fiber-Lax 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. do not take more than 4 doses in 24 hours adults & children 12 years and over: 2 captabs 1 to 4 times a day children under 12 years: ask a doctor Other information each captab contains: calcium 140 mg store below 30˚C (86˚F) • do not refrigerate • protect from humidity
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 generally produces bowel movement in 12 to 72 hours
Purpose
Information about the drug product’s indications for use.Purpose Bulk-Forming Laxative (equivalent to polycarbophil 500 mg)
Spl product data elements
Usually a list of ingredients in a drug product.Fiber Lax Calcium Polycarbophil CARAMEL CROSPOVIDONE, UNSPECIFIED 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.Fiber-Lax 55289949 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.TAMPER EVIDENT: DO NOT USE IF BLISTER SEAL IS BROKEN OR DAMAGED *Rugby Laboratories, Inc. is not affiliated with the owner of the trademark FiberCon®. Distributed by: Rugby Laboratories 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 www. Rugbylaboratories.com
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 noticed a sudden change in bowel habits that lasts over two 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.
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use longer than one week
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 1-800-645-2158
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 have rectal bleeding you fail to have a bowel movement after using this product. These may indicate a serious condition.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.16 HOW SUPPLIED Fiber-Lax Tablets are available as follows: 500 mg: Off White, oval, scored tablet, debossed “CPC 339”. Available in bottles of 30 captabs (NDC 55289-949-30)
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. Do not use longer than one week Ask a doctor before use if you have abdominal pain, nausea, or vomiting noticed a sudden change in bowel habits that lasts over two 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. Stop use and ask a doctor if you have rectal bleeding you fail to have a bowel movement after using this product. These may indicate a serious condition. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center 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