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- NDC Code(s): 57896-791-01, 57896-791-08
- Packager: Geri-Care Pharmaceuticals, Corp
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 26, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
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- Active ingredient (in each tablet)
Simethicone 80 mg
- Purpose
Anti-Gas
- Uses
relieves pressure, bloating, and fullness
commonly referred to as gas - Warnings
- Directions
- chew or crush tablet completely before swallowing
- adults and children 12 years and over: take 1-2 tablets as needed after meals and at bedtime.
Do not exceed 6 tablets in 24 hours except under the advice and supervision of a doctor.
- children under 12 years: ask a doctor
- Other information
- each tablet contains: calcium 65 mg
- Tamper Evident: Do not use if imprinted seal under cap is missing or broken
- store at room temperature, 15°C - 30°C (59˚F - 86˚F)
- protect from moisture
- Inactive ingredients
cellulose, corn starch, crospovidone, dextrates hydrated, flavor,
magnesium stearate, silica, sucralose, calcium phosphate. - Questions or comments?
1-800-540-3765
- package Label
- INGREDIENTS AND APPEARANCE
SIMETHICONE
simethicone tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57896-791 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 80mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) DEXTRATES (UNII: G263MI44RU) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TRICALCIUM PHOSPHATE (UNII: K4C08XP666) SUCRALOSE (UNII: 96K6UQ3ZD4) STARCH, CORN (UNII: O8232NY3SJ) CROSPOVIDONE (UNII: 2S7830E561) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color white Score no score Shape ROUND Size 13mm Flavor PEPPERMINT Imprint Code 44;137 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57896-791-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2016 2 NDC:57896-791-08 80 in 1 BOTTLE; Type 0: Not a Combination Product 08/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M002 01/01/2004 Labeler -Geri-Care Pharmaceuticals, Corp(611196254)
Registrant -Geri-Care Pharmaceuticals, Corp (611196254)
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Safety
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Related Resources
Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary
More Info on this Drug
View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!
View Labeling Archives for this drug
SIMETHICONE tablet, chewable
Number of versions: 5
| Published Date (What is this?) | Version | Files |
|---|---|---|
| Oct 27, 2023 | 5 (current) | download |
| Dec 1, 2022 | 4 | download |
| Oct 6, 2021 | 3 | download |
| Dec 28, 2017 | 2 | download |
| Mar 26, 2014 | 1 | download |
RxNorm
SIMETHICONE tablet, chewable
| RxCUI | RxNorm NAME | RxTTY | |
|---|---|---|---|
| 1 | 314216 | simethicone 80 MG Chewable Tablet | PSN |
| 2 | 314216 | simethicone 80 MG Chewable Tablet | SCD |
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SIMETHICONE tablet, chewable
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NDC Codes
SIMETHICONE tablet, chewable
If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.
| NDC | |
|---|---|
| 1 | 57896-791-01 |
| 2 | 57896-791-08 |
