FDA Label for Paroex
View Indications, Usage & Precautions
Paroex Product Label
The following document was submitted to the FDA by the labeler of this product Atlantic Biologicals Corp.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
To Open, Press Down While Turning The Cap. To Seal, Turn Until Cap Clicks And Is Tight.
Directions for Use: Fill dosage cup to the fill line (15 mL). Swish in your mouth undiluted for 30 seconds, then spit out. Use after breakfast and before bedtime. Or, use as prescribed by your dentist.
Note: To minimize medicinal taste, do not rinse with water immediately after use.
Rx Only.
Keep Out Of Reach Of Children.
What To Expect When Using Paroex® (Chlorhexidine Gluconate Oral Rinse Usp, 0.12%):
Your dentist has prescribed Paroex® to treat your gingivitis - to help reduce the redness and swelling of your gums, and also to help you control any gum bleeding.
Use Paroex® regularly, as directed by your dentist, in addition to daily brushing and flossing. Spit out after use. Paroex® should not be swallowed.
If you develop allergic symptoms such as skin rash, itch, generalized swelling, breathing difficulties, light headedness, rapid heart rate, upset stomach or diarrhea, seek medical attention immediately. Paroex® should not be used by persons who have a sensitivity to it or its components.
Paroex® may cause some tooth discoloration, or increases in tartar (calculus) formation, particularly in areas where stain and tartar usually form. It is important to see your dentist for removal of any stain and tartar at least every six months, or more frequently if your dentist advises.
- Both stain and tartar can be removed by your dentist or hygienist. Chlorhexidine gluconate oral rinse may cause permanent discoloration of some front-tooth fillings.
- To minimize discoloration, you should brush and floss daily, emphasizing areas which begin to discolor.
- Paroex® may taste bitter to some patients and can affect how foods and beverages taste. This will become less noticeable in most cases with continued use of Paroex®.
- To avoid taste interference, rinse with Paroex® after meals. Do not rinse with water or other mouthwashes immediately after rinsing with Paroex®.
If you have any questions or comments about Paroex®, contact your dentist, pharmacist or Sunstar Americas, Inc. at 1-800-528-8537. Call your health care provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
STORE at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP controlled room temperature].
Manufactured for: Sunstar Americas, Inc., Chicago, IL 60630
Principal Display Panel
NDC 17856-0210-1
5ml Unit Dose Cup
72 units in a Box
Distributed by:
Atlantic Biologicals Corp
Miami Fl 33179
NDC 17856-0210-2
10 ml Unit Dose Cup
72 units in a Box
Distributed by:
Atlantic Biologicals Corp
Miami Fl 33179
NDC 17856-0210-3
10 ml Unit Dose Cup
72 units in a Box
Distributed by:
Atlantic Biologicals Corp
Miami Fl 33179
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