Label: SIMETHICONE tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 55154-1480-0 - Packager: Cardinal Health
- This is a repackaged label.
- Source NDC Code(s): 63739-225
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated December 21, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Keep Out of Reach of Children
- Uses
- Warnings
- Directions
- Inactive ingredients
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Storage
STORE at Room Temperature. Avoid high humidity and excessive heat, above 40 C (104 F).
Mint Flavored chewable Tablets
Sky
Mfg. By: Guardian Drug Company
2 Charles Court
Dayton, NJ 08810
Distributed By
McKesson Packaging Services
a business unit of McKesson Corporation
7101 Weddington Road
Concord, NC 28027
Validated with McKesson's PROmanager-Rx Automated storage & dispensing system for Package-Ready Oral solids
www.PROmanager-Rx.com
Distributed by:
Cardinal Health
Dublin, OH 43017
L43456330318
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
SIMETHICONE
simethicone tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55154-1480(NDC:63739-225) 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 SUCROSE (UNII: C151H8M554) DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) MAGNESIUM (UNII: I38ZP9992A) STEARYL STEARATE (UNII: 5WX2EGD0DK) MALTODEXTRIN (UNII: 7CVR7L4A2D) SORBITOL (UNII: 506T60A25R) Product Characteristics Color WHITE Score no score Shape ROUND Size 6mm Flavor Imprint Code GDC;103 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55154-1480-0 10 in 1 BAG 06/06/2011 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 06/06/2011 Labeler - Cardinal Health (603638201)
