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NDC 17856-0791-01 SIMETHICONE 80 mg/1 Details
SIMETHICONE 80 mg/1
SIMETHICONE is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by ATLANTIC BIOLOGICALS CORP.. The primary component is DIMETHICONE.
MedlinePlus Drug Summary
Simethicone is used to treat the symptoms of gas such as uncomfortable or painful pressure, fullness, and bloating. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Related Packages: 17856-0791-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Simethicone
Product Information
NDC | 17856-0791 |
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Product ID | 17856-0791_44ad7d45-f84b-4866-a7f4-806a71baa104 |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | SIMETHICONE |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Simethicone |
Product Type | HUMAN OTC DRUG |
Dosage Form | TABLET, CHEWABLE |
Route | ORAL |
Active Ingredient Strength | 80 |
Active Ingredient Units | mg/1 |
Substance Name | DIMETHICONE |
Labeler Name | ATLANTIC BIOLOGICALS CORP. |
Pharmaceutical Class | Skin Barrier Activity [PE] |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH FINAL |
Application Number | part332 |
Listing Certified Through | 2023-12-31 |
Package
Package Images

NDC 17856-0791-01 (17856079101)
NDC Package Code | 17856-0791-1 |
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Billing NDC | 17856079101 |
Package | 50 POUCH in 1 BOX (17856-0791-1) / 1 TABLET, CHEWABLE in 1 POUCH (17856-0791-2) |
Marketing Start Date | 2022-04-11 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL e07aebe8-3c58-4bf0-9e80-66d430e2de9b Details
Warnings
Directions
Other information
Inactive ingredients
INGREDIENTS AND APPEARANCE
SIMETHICONE
simethicone tablet, chewable |
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Labeler - ATLANTIC BIOLOGICALS CORP. (047437707) |
Registrant - ATLANTIC BIOLOGICALS CORP. (047437707) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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UNIT DOSE SOLUTIONS | 360804194 | repack(17856-0791) |
Revised: 5/2022
Document Id: 44ad7d45-f84b-4866-a7f4-806a71baa104
Set id: e07aebe8-3c58-4bf0-9e80-66d430e2de9b
Version: 6
Effective Time: 20220519