Premier Value 625 mg/1
Calcium Polycarbophil · TABLET, FILM COATED · PHARMACY VALUE ALLIANCE, LLC
Premier Value is a tablet, film coated containing calcium polycarbophil at 625 mg/1, taken oral. Manufactured by PHARMACY VALUE ALLIANCE, LLC.
Key Facts
- Brand Name
- Premier Value
- Generic Name
- Calcium Polycarbophil
- NDC Code (Product)
68016-220- Manufacturer
- PHARMACY VALUE ALLIANCE, LLC
- Strength
- 625 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- M007
- Marketing Start
- 04/16/2019
Recall History
Aaron Industries Inc
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles.
Product Quest Manufacturing LLC
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Raritan Pharmaceuticals, Inc.
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
Vi-Jon, Inc.
Microbial contamination of non-sterile products: product was found to contain mold, identified as Rhinocladiella similis.
Humco Holding Group, Inc
Microbial Contamination of Non-Sterile Product(s): The product was found to be contaminated with Bulkholderia sp.
Vi-Jon, LLC
Cross Contamination With Other Products: Product is cross contaminated with low levels of isopropyl alcohol.
Akorn, Inc.
Presence of Particulate Matter
Seaway Pharma Inc.
CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
Vi-Jon, LLC
CGMP Deviations
Product Quest Manufacturing LLC
Superpotent Drug: high out of specification assay results for the menthol ingredient.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Uses relieves: • heartburn • sour stomach • acid indigestion • upset stomach associated with these symptoms
Dosage & Administration
Directions • adults and children 12 years of age and over: chew 2-4 tablets as symptoms occur, or as directed by a doctor. Do not swallow tablets whole. • do not take for symptoms that persist for more than 2 weeks unless advised by a doctor
Warnings
Warnings Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs. When using this product • do not take more than 15 tablets in 24 hours • do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor
Frequently Asked Questions
What is Premier Value used for?
Premier Value contains Calcium Polycarbophil. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Premier Value a controlled substance?
Premier Value is not classified as a controlled substance by the DEA.
What is the generic name for Premier Value?
The generic name for Premier Value is Calcium Polycarbophil. There are 12 other brand versions of Calcium Polycarbophil.
What is the NDC code for Premier Value 625 mg/1?
The NDC (National Drug Code) for Premier Value 625 mg/1 is 68016-220, listed by PHARMACY VALUE ALLIANCE, LLC.
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- Meijer Fiber Caplets625 mg/179481-1205
- Fiber Lax625 mg/155289-949
- Foster and Thrive Fiber Laxative 147625 mg/170677-1083
- Fiber laxative625 mg/153943-147
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)