Sunmark Gas Relief
FDA Label NDC 49348-509

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mckesson for the product Sunmark Gas Relief (NDC 49348-509). 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 tablet), purpose, otc - keep out of reach of children, uses, warnings, directions, inactive ingredients, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Tablet)

Simethicone 80 mg

Purpose

Anti-gas

Otc - Keep Out Of Reach Of Children

Uses

relieves

  • pressure
  • bloating
  • symptoms referred to as gas

Warnings

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Directions

  • chew 1 to 2 tablets thoroughly as needed after meals and at bedtime
  • do not exceed 6 tablets per day unless directed by a physician.

    • Other information

    • do not use if any individual blister unit is broken or open.
    • store at room temperature.
    • avoid high humidity and excessive heat, above 40°C (104°F)

Inactive Ingredients

compressible sugar, dextrose, flavors, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol

Principal Display Panel

Sunmark

COMPARE TO GAS-X® ACTIVE INGREDIENT

gas relief

Regular Strength

Fast relief of pressure, bloating & discomfort of gas

SIMETHICONE 80 mg

Peppermint creme

36 Chewable Tablets

Pdp (156f)

Pdp (156f)

Text (156b)

Text (156b)

* Please review the disclaimer below.