Simethicone
FDA Label NDC 68210-1901

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Spirit Pharmaceuticals,llc for the product Simethicone (NDC 68210-1901). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (per softgel), purpose, use, directions, other information, inactive ingredients, principal display panel - 125 mg label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (Per Softgel)

Simethicone 125 mg

Purpose

Antigas

Use

for the relief of

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

Directions

  • adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime
  • do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician

Other Information

  • store at a controlled room temperature 20-25°C (68-77°F)
  • protect from light, heat and moisture

Inactive Ingredients

D&C yellow 10, FD&C blue 1, FD&C red 40, gelatin, glycerin, hypromellose, peppermint oil, purified water, sorbitol, titanium dioxide

Principal Display Panel - 125 Mg Label

SIMETHICONE CAPSULES USP 125MG

Each Softgel Contains:
(Simethicone USP 125 mg)

LOT NO:QUANTITY:
DRUM NO:NDC NO: 68210-1901-
MFG DATE:EXP DATE:

WARNING:
KEEP OUT OF REACH OF CHILDREN

STORE CONTROLLED ROOM TEMPERATURE OF 59° – 86°F (15° – 30°C)
PROTECT FROM LIGHT, MOISTURE AND FREEZING

THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.
CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT
CONFORMANCE WITH THE F.D&C ACT AND REGULATIONS THEREUNDER.

MANUFACTURED BY:
SOFTGEL HEALTHCARE PVT LIMITED
INDIA
LABELLER CODE           : 35916
LIC NO.                              : TN/DRUGS/00002124

MANUFACTURED FOR:
SPIRIT PHARMACEUTICALS LLC
225 LINCOLN HWY, STE 205
FAIRLESS HILLS, PA 19030
PH.# 215 943 4000
FAX.# 215 943 4039

CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"

Principal Display Panel (125 mg Label)

Principal Display Panel (125 mg Label)

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