Drugplain

Antiplaque solution .5 mg/mL

CETYLPYRIDINIUM CHLORIDE · MOUTHWASH · Sage Products LLC

9 Recalls on Record
Plain English

Antiplaque solution is a mouthwash containing cetylpyridinium chloride at .5 mg/mL, taken buccal. Manufactured by Sage Products LLC.

Key Facts

Brand Name
Antiplaque solution
Generic Name
CETYLPYRIDINIUM CHLORIDE
NDC Code (Product)
53462-275
Manufacturer
Sage Products LLC
Strength
.5 mg/mL
Dosage Form
MOUTHWASH
Route
BUCCAL
Marketing Status
Application #
M022
Marketing Start
01/09/2009

Recall History

9 Recalls on Record
Class II08/22/2017

Sage Products Inc

Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products

TerminatedVoluntary: Firm initiated
Class II08/22/2017

Sage Products Inc

Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products

TerminatedVoluntary: Firm initiated
Class II08/22/2017

Sage Products Inc

Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products

TerminatedVoluntary: Firm initiated
Class II08/22/2017

Sage Products Inc

Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products

TerminatedVoluntary: Firm initiated
Class II08/22/2017

Sage Products Inc

Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products

TerminatedVoluntary: Firm initiated
Class II08/22/2017

Sage Products Inc

Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products

TerminatedVoluntary: Firm initiated
Class II08/22/2017

Sage Products Inc

Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products

TerminatedVoluntary: Firm initiated
Class II08/22/2017

Sage Products Inc

Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products

TerminatedVoluntary: Firm initiated
Class II08/22/2017

Sage Products Inc

Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

nausea21 reports
vomiting17 reports
off label use16 reports
fatigue15 reports
back pain14 reports
sepsis14 reports
pain13 reports
rash12 reports
dyspnoea11 reports
pneumonia11 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses Aids in the removal and prevention of plaque that leads to gingivitis.

Dosage & Administration

Directions Before opening, turn package over, burst solution packet with thumbs. Peel lid to open. Remove Mouth Moisturizer and Applicator Swab. Attach Toothbrush to suction line. Clean teeth and oral cavity for approximately one minute. To suction, place thumb over port. To clear tubing, rinse with sterile saline or appropriate solution. Discard Toothbrush. Reattach Covered Yankauer to suction line. Place Mouth Moisturizer on Applicator Swab. Apply as needed to lips and inside mouth. Adults and children 12 years of age and older: use two times daily or as directed by a dentist. Do not swallow the solution. Children ages 6 to 12 years: supervise use. Children under 6 years of age: do not use. Use a bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands. Ensure foam is intact after use. If not, remove any particles from oral cavity.

Warnings

Warnings Stop use and ask a dentist if: Gingivitis, bleeding or redness persists for more than 2 weeks. You have painful or swollen gums, pus from the gum line, loose teeth or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease. Keep out of reach of children under 6 year of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is Antiplaque solution used for?

Antiplaque solution contains CETYLPYRIDINIUM CHLORIDE. It is a mouthwash taken buccal. Consult your doctor for specific uses.

Is Antiplaque solution a controlled substance?

Antiplaque solution is not classified as a controlled substance by the DEA.

What is the generic name for Antiplaque solution?

The generic name for Antiplaque solution is CETYLPYRIDINIUM CHLORIDE. There are 11 other brand versions of CETYLPYRIDINIUM CHLORIDE.

What is the NDC code for Antiplaque solution .5 mg/mL?

The NDC (National Drug Code) for Antiplaque solution .5 mg/mL is 53462-275, listed by Sage Products LLC.