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| Product NDC Code | 83931-001 | ||||
|---|---|---|---|---|---|
| Drug Name | Simethicone enteric s.c. |
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| Type | Brand | ||||
| Pharm Class | Skin Barrier Activity [PE] | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET, SUGAR COATED | ||||
| RxCUI drug identifier | 312959 | ||||
| Application Number | M002 | ||||
| Labeler Name | Synmosa Biopharma Corporation Synmosa Plant | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each sugar-coated tablet) Simethicone 60 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions Adults and children over 12 years: one or two tablets daily, taken with meal or at bedtime. Do not exceed 8 tablets per day except under the advice and supervision of a physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Calcium Phosphate Dibasic, Carnauba Wax, Corn Starch, FD&C Red No. 3 (Erythrosine), Gelatin, Corn Starch (Pregelatinized), Lactose Monohydrate, Hypromellose Phthalate (31% phthalate, 40 CST), Polyoxyl 40 Stearate, Polysorbate 80, Povidone K-30, Sucrose granules, Sodium Starch Glycolate, Talc, Titanium
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Use Relief of bloating and pressure commonly referred to as gas.
Purpose
Information about the drug product’s indications for use.Purpose Anti-gas
Spl product data elements
Usually a list of ingredients in a drug product.Simethicone Enteric S.C. Simethicone POLYOXYL 40 STEARATE FD&C RED NO. 3 HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST) POLYSORBATE 80 SUCROSE CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS TALC STARCH, CORN LACTOSE MONOHYDRATE POVIDONE K30 TITANIUM DIMETHICONE DIMETHICONE SODIUM STARCH GLYCOLATE TYPE A CARNAUBA WAX GELATIN
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.synmosa ANTI-GAS Simethicone Enteric S.C. Tablets 60 mg Keep outer carton for complete warnings and product information OTC Anti-Gas Ingredient 100 Tablets label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Simethicone Enteric S.C. Tablets 60 mg Composition: Each S.C. tablet contains: Simethicone . . . . . 60 mg Anti Gas Acts Fast to Relieve Gas Pressure Bloating Gas Discomfort Manufactured by: Synmosa Biopharma Corporation,Synmosa Plant No. 6, Kuang Yeh 1 st Road, Hu-Kuo Hsiang Hsin-Chu Ind. Park, Hsin Chu Hsien Taiwan, R.O.C. Made in Taiwan (R.O.C.)
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.TAMPER EVIDENT Do not use if blister unit is torn, broken or shows any signs of tampering.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? https://www.synmosa.com.tw/en/Inquiry/ugC_Inquiry.asp
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store below 25°C (77°F).
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API