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| Product NDC Code | 68016-220 | ||||
|---|---|---|---|---|---|
| Drug Name | Premier value |
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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 | PHARMACY VALUE ALLIANCE, LLC | ||||
| Packages |
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Overdosage of Premier Value
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 at 1-800-222-1222.
Active ingredient
A list of the active, medicinal ingredients in the drug product.Drug Fats Active Ingredient (in each caplet) Calcium polycarbophil 625 mg equivalent to 500 mg polycarbophil
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 each dose of 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). ▪ This product works naturally so continued use for one to three days is normally required to provide full benefit. Dosage may vary according to diet, exercise, previous laxative use or severity of constipation. Age Recommended Daily maximum adults & children 12 years of age and over 2 caplets once a day up to 4 times a day children under 12 years consult a physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.calcium carbonate, caramel color, crospovidone, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, , polyethylene glycol, silicon dioxide, sodium lauryl sulfate.
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 to help restore and maintain 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.Premier Value Calcium Polycarbophil CALCIUM POLYCARBOPHIL POLYCARBOPHIL CALCIUM CARBONATE CARAMEL CROSPOVIDONE (120 .MU.M) HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MALTODEXTRIN MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED SILICON DIOXIDE SODIUM LAURYL SULFATE RP120
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# 68016-220-25 Premier Value ® COMPARE TO THE ACTIVE INGREDIENTS FIBERCON ® CAPLETS* Fiber Caplets Calcium Polycarbophil 625 mg Bulk-Forming Fiber Laxative • Gentle Relief of Constipation • Won’t Cause Gas or Bloating • Effective as Fiber Powders 250 CAPLETS If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund. Distributed By: Pharmacy Value Alliance, LLC 407 East Lancaster Avenue, Wayne, PA 19087 *This product is not manufactured or distributed by Pfizer Inc., owner of the registered trademark Fibercon® Caplets Premier Value Fiber Caplets 250 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.OTHER INFORMATION • each caplet contains: calcium 125 mg • store at room temperature • protect contents from moisture Safety sealed: Do not use if imprinted safety seal under cap is broken or missing
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 your doctor or pharmacist before use if you are taking any other drug. Take this product 2 or more hours before or after other drugs. All 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.
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? 1-866-467-2748
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 rectal bleeding occurs or if you fail to have a bowel movement after use of this or any other laxative. 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 Warning: 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 your doctor or pharmacist before use if you are taking any other drug. Take this product 2 or more hours before or after other drugs. All 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 rectal bleeding occurs or if you fail to have a bowel movement after use of this or any other laxative. 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 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