Premier Value 5.8 mg/1
Cough Drops Black Cherry Sugar Free · LOZENGE · Pharmacy Value Alliance LLC
Premier Value is a lozenge containing cough drops black cherry sugar free at 5.8 mg/1, taken oral. Manufactured by Pharmacy Value Alliance LLC.
Key Facts
- Brand Name
- Premier Value
- Generic Name
- Cough Drops Black Cherry Sugar Free
- NDC Code (Product)
68016-886- Manufacturer
- Pharmacy Value Alliance LLC
- Strength
- 5.8 mg/1
- Dosage Form
- LOZENGE
- Route
- ORAL
- Marketing Status
- Application #
- M012
- Marketing Start
- 07/31/2023
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 Cough Drops Black Cherry Sugar Free. It is a lozenge 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 Cough Drops Black Cherry Sugar Free. There are 3 other brand versions of Cough Drops Black Cherry Sugar Free.
What is the NDC code for Premier Value 5.8 mg/1?
The NDC (National Drug Code) for Premier Value 5.8 mg/1 is 68016-886, listed by Pharmacy Value Alliance LLC.