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NDC 70518-1813-00 Simethicone 125 mg 125 mg/1 Details
Simethicone 125 mg 125 mg/1
Simethicone 125 mg is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by REMEDYREPACK INC.. 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: 70518-1813-00Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Simethicone
Product Information
NDC | 70518-1813 |
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Product ID | 70518-1813_da303b38-c908-b559-e053-2995a90ad08b |
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 125 mg |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Simethicone |
Product Type | HUMAN OTC DRUG |
Dosage Form | TABLET, CHEWABLE |
Route | ORAL |
Active Ingredient Strength | 125 |
Active Ingredient Units | mg/1 |
Substance Name | DIMETHICONE |
Labeler Name | REMEDYREPACK INC. |
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 70518-1813-00 (70518181300)
NDC Package Code | 70518-1813-0 |
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Billing NDC | 70518181300 |
Package | 30 POUCH in 1 BOX (70518-1813-0) / 1 TABLET, CHEWABLE in 1 POUCH (70518-1813-1) |
Marketing Start Date | 2019-01-23 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 75309f5a-96bb-4825-8ab5-19d6065248e7 Details
Directions
Inactive ingredients
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL
DRUG: Simethicone 125 mg
GENERIC: Simethicone
DOSAGE: TABLET, CHEWABLE
ADMINSTRATION: ORAL
NDC: 70518-1813-0
NDC: 70518-1813-1
COLOR: white
SHAPE: ROUND
SCORE: Two even pieces
SIZE: 16 mm
IMPRINT: AP;040
PACKAGING: 1 in 1 POUCH
OUTER PACKAGING: 30 in 1 BOX
ACTIVE INGREDIENT(S):
- DIMETHICONE 125mg in 1
INACTIVE INGREDIENT(S):
- SUCROSE
- MALTODEXTRIN
- PEPPERMINT
- SORBITOL
- STEARIC ACID
- DEXTROSE
- CELLULOSE, MICROCRYSTALLINE
- SILICON DIOXIDE
INGREDIENTS AND APPEARANCE
SIMETHICONE 125 MG
simethicone tablet, chewable |
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Labeler - REMEDYREPACK INC. (829572556) |
Revised: 3/2022
Document Id: da303b38-c908-b559-e053-2995a90ad08b
Set id: 75309f5a-96bb-4825-8ab5-19d6065248e7
Version: 4
Effective Time: 20220314