Label: PLUSPHARMA- simethicone tablet, chewable
- NDC Code(s): 63187-516-00
- Packager: Proficient Rx LP
- This is a repackaged label.
- Source NDC Code(s): 51645-860
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 1, 2021
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- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
- Warnings
- Directions
- Other Information
- Inactive ingredients
- Questions?
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Principal Display Panel
PlusPHARMA
SIMETHICONE 80 mg
ANTI GAS
Acts Fast to Relieve:
- •
- Bloating
- •
- Discomfort
- •
- Pressure
Compare to the Active Ingredient in Gas-X® Chewables.
This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Gas-X® Chewables.
100 CHEWABLE TABLETS 80mg Each
Relabeled by:
Proficient Rx LP
Thousand Oaks, CA 91320
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INGREDIENTS AND APPEARANCE
PLUSPHARMA
simethicone tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63187-516(NDC:51645-860) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 80 mg Inactive Ingredients Ingredient Name Strength FRUCTOSE (UNII: 6YSS42VSEV) MALTODEXTRIN (UNII: 7CVR7L4A2D) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SORBITOL (UNII: 506T60A25R) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score no score Shape ROUND (Round Flat Faced Beveled Edge) Size 13mm Flavor SPEARMINT (Natural and Artificial) Imprint Code GPI;LB Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63187-516-00 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 03/27/2006 Labeler - Proficient Rx LP (079196022) Establishment Name Address ID/FEI Business Operations Proficient Rx LP 079196022 REPACK(63187-516) , RELABEL(63187-516)