FDA.reportPublic FDA data

660R - Target Simethicone 125 mg Chewable tablets - Cherry Flavor

Manufacturer
TARGET CORPORATION | TIME CAP LABORATORIES | MARKSANS PHARMA LIMITED
Effective date
2025-04-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:05:59

Label at a glance#

ProductGas Relief - Cherry Flavor
Active ingredientDIMETHICONE
Label structure11 sections

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Simethicone 125 mg

OTC - PURPOSE SECTION

Purpose

Antigas

INDICATIONS & USAGE SECTION

Use for the relief of

  • pressure, bloating, and fullness commonly referred to as gas

WARNINGS SECTION

Warning

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions

  • adults and children 12 years and older: chew 1 or 2 tablets as needed after meals and at bedtime. Chew or crush tablets completely before swallowing.
  • do not exceed 4 tablets in 24 hours except under the advice and supervision of a physician

OTHER SAFETY INFORMATION

Other information

  • Store at controlled room temperature 20-25°C (68-77 °F).
  • Protect from moisture

INACTIVE INGREDIENT SECTION

Inactive ingredients

acacia, D&C red no. 30 aluminum lake, dextrose monohydrate, FD&C red no. 40 aluminum lake, flavors, guar gum, magnesium stearate, maltodextrin, silicified microcrystalline cellulose, silicon dioxide, sodium stearyl fumarate, sorbitol, sucralose, sucrose, tribasic calcium phosphate

OTC - QUESTIONS SECTION

Questions or comments? Call 1-800-910-6874

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

660R 48s_IFC660R 48s_IFC

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
314221simethicone 125 MG Chewable TabletPSN2
314221simethicone 125 MG Chewable TabletSCD2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11673-066-48Gas Relief - Cherry Flavor12 in 1 BLISTER PACKTABLET, CHEWABLE122
11673-066-48Gas Relief - Cherry Flavor4 in 1 CARTONTABLET, CHEWABLE42

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11673-06611673-066-48

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
GUAR GUME89I1637KEIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ACACIA5C5403N26OIACT
SORBITOL506T60A25RIACT
SILICIFIED MICROCRYSTALLINE CELLULOSE (65 ?M)K2EZE348C4IACT
SODIUM STEARYL FUMARATE7CV7WJK4UIIACT
D&C RED NO. 30 ALUMINUM LAKEGE75M6YV5WIACT
DEXTROSE MONOHYDRATELX22YL083GIACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT
FD&C RED NO. 40 ALUMINUM LAKE6T47AS764TIACT
SUCRALOSE96K6UQ3ZD4IACT
SUCROSEC151H8M554IACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
DIMETHICONE92RU3N3Y1OACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gas Relief - Cherry FlavorSIMETHICONETARGET CORPORATION290fe08d-a0b9-82f7-e063-6394a90a9c752025-04-11WarningsExact identifier
ndc (package): 11673-066-48
ndc (product): 11673-066
ndc11 (package): 11673006648
spl id: 327e49c2-ceae-7d94-e063-6394a90a3b19
spl set id: 290fe08d-a0b9-82f7-e063-6394a90a9c75

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.