Simethicone
FDA Label NDC 55629-017

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by One2zee Limited Liability Company for the product Simethicone (NDC 55629-017). 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 (in each capsule), purpose, uses, stop use and ask a doctor if, directions, other information, inactive ingredients, principal display panel - shipping label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Capsule)

Simethicone 250 mg

Purpose

Anti-gas

Uses

  • relieves bloating, pressure or fullness commonly referred to as gas

Stop Use And Ask A Doctor If

condition persists

Directions

  • swallow one or two softgels after a meal
  • do not exceed two softgels per 24 hours except under the advice and supervision of a physician

Other Information

  • store at room temperature 59°-86°F (15°-30°C

Inactive Ingredients

gelatin, glycerin, sorbitol, fd&c blue no. 1, fd&c red no. 40, povidone k30, titanium dioxide, water

Principal Display Panel - Shipping Label

Simethicone capsules

Each Softgel Contains:
(Simethicone 250mg)

LOT NO:
DRUM NO:
MFG DATE:
QUANTITY:
NDC NO: 55629-017-
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.

* Please review the disclaimer below.