openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 2 matching rows.
warnings
Warnings Stop use and ask a doctor if: Swelling, rash, or fever develop. Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting occurs. Do not use more than 2 days or administer to children under 3 years of age unless directed by a physician. Keep out of reach of children under 3 years of age.
warnings
WARNINGS The effect of Chlorhexidine Gluconate Oral Rinse, 0.12% on periodontitis has not been determined. An increase in supragingival calculus was noted in clinical testing in users of chlorhexidine gluconate oral rinse compared with control users. It is not known if chlorhexicine gluconate use results in an increase in subgingival calculus. Calculus deposits should be removed by a dental prophylaxis at intervals not greater than six months. Hypersensitivity and generalized allergic reactions have occurred. See CONTRAINDICATIONS .
ADVERSE REACTIONS The most common side effects associated with chlorhexidine gluconate oral rinses are: 1) an increase in staining of teeth and other oral surfaces; 2) an increase in calculus formation; and 3) an alteration in taste perception, see WARNINGS and PRECAUTIONS . Oral irritation and local allergy-type symptoms have been spontaneously reported as side effects associated with use of chlorhexidine gluconate rinse. The following oral mucosal side effects were reported during placebo-controlled adult clinical trials: aphthous ulcer, grossly obvious gingivitis, trauma, ulceration, erythema, desquamation, coated tongue, keratinization, geographic tongue, mucocele, and short frenum. Each occurred at a frequency of less than 1.0%. Among post marketing reports, the most frequently reported oral mucosal symptoms associated with chlorhexidine gluconate oral rinse, 0.12% are stomatitis, gingivitis, glossitis, ulcer, dry mouth, hypesthesia, glossal edema, and paresthesia. Minor irritation and superficial desquamation of the oral mucosa have been noted in patients using chlorhexidine gluconate oral rinse, 0.12%. There have been cases of parotid gland swelling and inflammation of the salivary glands (sialadentis) reported in patients using chlorhexidine gluconate oral rinse. To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.