Simethicone Infant Suspension
FDA Label NDC 17856-1018

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Atlantic Biologicals Corp. for the product Simethicone Infant (NDC 17856-1018). 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 0.3 ml), purpose, uses, directions, other information, inactive ingredients, questions or comments ?, package label.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 0.3 Ml)

Simethicone 20 mg

Purpose

Antigas

Uses

relieves the symptoms referred to as gas

Directions

  • shake well before using
  • all dosages may be repeated as needed, alter meals and at bedtime, or as directed by a physician
  • do not exceed 12 doses per day
  • fill enclosed dropper to recommended dosage level and dispense liquid slowly into baby's mouth, toward the inner cheek
  • dosage can also be mixed with 1 oz. of cool water, infant formula or other suitable liquids

    • Age (years)

    Weight (lbs)

    Dose

    infants (under 2)

    under 24

    0.3 mL

    children (2 and over)

    24 and over

    0.6 mL

Other Information

  • TAMPER-EVIDENT:Do not use if printed seal under cap is broken or punctured
  • store at room temperature
  • do not freeze
  • see bottom panel for lot number and expiration date

Inactive Ingredients

Carboxymethylcellulose sodium, Citric acid, Flavor strawberry, Microcrystalline cellulose, Polysorbate 60, Potassium sorbate, Purified water, Sodium benzoate, Sorbitan monostearate, Sorbitol solution, Xanthan gum.

Questions Or Comments ?

To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or https://www.fda.gov/medwatch/report.htm

Distributed By:

Atlantic Biologicals Corp.

Miami, FL 33179

Package Label.Principal Display Panel

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