FDA Label for Eton Q
View Indications, Usage & Precautions
Eton Q Product Label
The following document was submitted to the FDA by the labeler of this product Chong Kun Dang Pharm. 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.
Active Ingredient
Active ingredient (In each tablet)
ZEA MAYS WHOLE (Titrated Extract of Zea Mays L. Unsaponifiable Fraction)………………35.0mg (equal to 7mg β-sitosterol)
Inactive Ingredients
Microcrystalline Cellulose, Corn Starch, Colloidal Silicon Dioxide, Povidone (K-30), Kaolin, Magnesium Stearate
Purpose
Treatment for gingivitis and mild/moderate periodontitis
Warnings
Do not use
■ If you are hypersensitive to Zea Mays L. or any of the inactive ingredients in this drug ■ Ask a doctor of pharmacist before use if you are applicable to following conditions: 1) Azo pigments; Use with caution in patients with hypersensitivity to acetylsalicylic acid or other prostaglandin synthase inhibitors.do. 2) Be careful as this drug may interfere with the absorption of cholesterol drugs. 3) Pregnant or likely to be pregnant. Women who are pregnant or are breast-feeding (the safety of administration during pregnancy has not been established, so pregnant or breast-feeding women who may be pregnant). For women, it is administered only when it is judged that the therapeutic benefit outweighs the risk.) 4) This drug contains Yellow No. 4(Atrazine), Yellow No. 5(Sunset Yellow FCF). Please, consult your doctor, dentist, or pharmacist before taking if you are hypersensitive or allergic any of the ingredients in this drug ■ In the following cases, stop taking this drug immediately and consult a doctor, dentist or pharmacist. Whenever possible, carry this information with you. 1) May cause mild laxative effects. 2) If this drug is administered to a patient with asthma, chronic urticaria, or hypersensitivity to nonsteroidal anti-inflammatory drugs, it may cause hypersensitivity to the skin or respiratory system. 3) As a result of a clinical trial conducted on patients with periodontal disease to evaluate the efficacy and safety of this drug in Korea, taking this drug (3 times a day for 4 weeks, 2 tablets at a time, 4 weeks to 12 weeks) The adverse reactions reported in 72 patients who took this drug 3 times a day, 1 tablet at a time, for a total of 12 weeks) were as follows, regardless of the causal relationship. Nasopharyngitis (2 cases), dental abscess (pus), abdominal pain (belly pain), tooth fracture, AST increase, ALT increase, glaucoma, hyperlipidemia, pain in limbs, tooth extraction (extraction) (1 case each). 4) If there is no improvement in symptoms even after taking it for more than 1 month.■ Other precautions when taking this drug. 1) Be sure to follow the prescribed usage and dosage. 2) Do not take this drug continuously for a long time.
Keep Out Of Reach Of Children
NA
Uses
■ Adjuvant treatment for gingivitis
■ Mild/moderate periodontitis after periodontal treatment
Directions
■ Administration
Adults: take orally. In initial, take 2 tablets three times per day before meals (on empty stomach). For maintenance, take 1 tablet three times a day in empty before meals (on empty stomach). Appropriately increase or decrease amount of administration according to your age and symptoms.
Other Information
■ Storage at room temperature between 1~30℃ (33.8~86.0 °F) ■ Do not use if carton is opened ■ Do not use if foil inner seal is broken or missing ■ Keep out of reach of children ■ Store at a cool and dry place, away from direct sunlight and high temperature ■ Taking drugs out of their original containers and storing them in other containers may cause misuse or deterioration of drugs, therefore, put them in the original containers and keep them tightly closed.
Questions
■ Call +82-080-6776-080 ■ Website: http://www.ckdpharm.com
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