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Gas Relief - Cherry Flavor

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

Approved
Approval ID

290fe08d-a0b9-82f7-e063-6394a90a9c75

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Apr 11, 2025

Manufacturers
FDA

TARGET CORPORATION

DUNS: 006961700

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Simethicone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code11673-066
Application NumberM002
Product Classification
M
Marketing Category
C200263
G
Generic Name
Simethicone
Product Specifications
Route of AdministrationORAL
Effective DateApril 11, 2025
FDA Product Classification

INGREDIENTS (15)

GUAR GUMInactive
Code: E89I1637KE
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SILICIFIED MICROCRYSTALLINE CELLULOSE (65 ?M)Inactive
Code: K2EZE348C4
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
D&C RED NO. 30 ALUMINUM LAKEInactive
Code: GE75M6YV5W
Classification: IACT
DEXTROSE MONOHYDRATEInactive
Code: LX22YL083G
Classification: IACT
TRIBASIC CALCIUM PHOSPHATEInactive
Code: 91D9GV0Z28
Classification: IACT
FD&C RED NO. 40 ALUMINUM LAKEInactive
Code: 6T47AS764T
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
DIMETHICONEActive
Quantity: 125 mg in 1 1
Code: 92RU3N3Y1O
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/1/2025

660R 48s_IFC

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/1/2025

Use for the relief of

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 9/1/2025

Drug Facts

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/1/2025

Active ingredient (in each tablet)

Simethicone 125 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/1/2025

Purpose

Antigas

WARNINGS SECTION

LOINC: 34071-1Updated: 9/1/2025

Warning

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/1/2025

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/1/2025

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

LOINC: 60561-8Updated: 9/1/2025

Other information

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/1/2025

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

LOINC: 53413-1Updated: 9/1/2025

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Gas Relief - Cherry Flavor - FDA Drug Approval Details