Drugplain

Best Choice .05 g/100mL

oxymetazoline hydrochloride · SPRAY · BEST CHOICE (VALU MERCHANDISERS COMPANY)

10 Recalls on Record
Plain English

Best Choice is a spray containing oxymetazoline hydrochloride at .05 g/100mL, taken nasal. Manufactured by BEST CHOICE (VALU MERCHANDISERS COMPANY).

Key Facts

Brand Name
Best Choice
Generic Name
oxymetazoline hydrochloride
NDC Code (Product)
63941-716
Manufacturer
BEST CHOICE (VALU MERCHANDISERS COMPANY)
Strength
.05 g/100mL
Dosage Form
SPRAY
Route
NASAL
Marketing Status
Application #
M012
Marketing Start
05/16/2019

Recall History

10 Recalls on Record
Class II08/03/2018

Product Quest Manufacturing LLC

CGMP Deviations: products manufactured under conditions that could impact its product quality.

TerminatedVoluntary: Firm initiated
Class II06/28/2022

Vi-Jon, LLC

Cross Contamination With Other Products: Product is cross contaminated with low levels of isopropyl alcohol.

TerminatedVoluntary: Firm initiated
Class III12/04/2014

K C Pharmaceuticals Inc

CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.

TerminatedVoluntary: Firm initiated
Class III12/04/2014

K C Pharmaceuticals Inc

CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.

TerminatedVoluntary: Firm initiated
Class II03/03/2026

K.C. Pharmaceuticals, Inc

Lack of Assurance of Sterility

OngoingVoluntary: Firm initiated
Class II07/15/2022

Vi-Jon, LLC

CGMP Deviations

TerminatedVoluntary: Firm initiated
Class III12/04/2014

K C Pharmaceuticals Inc

CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.

TerminatedVoluntary: Firm initiated
Class II09/04/2012

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.

TerminatedVoluntary: Firm initiated
Class II03/03/2026

K.C. Pharmaceuticals, Inc

Lack of Assurance of Sterility

OngoingVoluntary: Firm initiated
Class II07/15/2022

Vi-Jon, LLC

CGMP Deviations;

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

fatigue36,298 reports
dyspnoea30,465 reports
nausea30,205 reports
diarrhoea29,592 reports
drug ineffective25,106 reports
dizziness24,476 reports
off label use22,699 reports
headache22,596 reports
pain21,816 reports
asthenia20,927 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses relieves heartburn acid indigestion sour stomach 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 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 presently taking a prescription drug. Antacids may interact with certain prescription drug. When using this product do not take more than 10 tablets in 24 hours if pregnant do not take more than 6 tablets in 24 hours do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor Keep out of reach of children.

Frequently Asked Questions

What is Best Choice used for?

Best Choice contains oxymetazoline hydrochloride. It is a spray taken nasal. Consult your doctor for specific uses.

Is Best Choice a controlled substance?

Best Choice is not classified as a controlled substance by the DEA.

What is the generic name for Best Choice?

The generic name for Best Choice is oxymetazoline hydrochloride. There are 11 other brand versions of oxymetazoline hydrochloride.

What is the NDC code for Best Choice .05 g/100mL?

The NDC (National Drug Code) for Best Choice .05 g/100mL is 63941-716, listed by BEST CHOICE (VALU MERCHANDISERS COMPANY).