Premier Value Infants Gas Relief Emulsion
FDA Label NDC 68016-670

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Consortium for the product Premier Value Infants Gas Relief (NDC 68016-670). 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, 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 discomfort of infant gas frequently caused by air swallowing or certain formulas or foods

Directions

  • shake well before using
  • all dosages may be repeated as needed, after 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. cool water, infant formula or other suitable liquids
  • clean dropper after each use - replace bottle with original cap

    • age (yr)

    weight (lb)

    dose

    infants under 2

    under 24

    0.3 mL

    children over 2

    over 24

    0.6 mL

Other Information

  • do not use if printed seal under cap is torn or missing
  • store at room temperature
  • do not freeze
  • see bottom panel for lot and expiration date

Inactive Ingredients

carboxymethylcellulose sodium, citric acid, microcrystalline cellulose, natural flavors, PEG-40 monostearate, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol.

Principal Display Panel

Compare to active ingredient in Mylicon® Infants' Drops

Premier Value

Infants' Drops

Gas Relief

Simethicone 20 mg

Non-Staining formula

Dye Free/Alcohol Free

No artificial flavors

Safe enough to use at every feeding

1 Fl. OZ (30ml)

100 Doses

Distributed by

Chain Drug Consortium, LLC.

3301 N.W. Boca Raton Blvd.,

Suite 101, Boca Raton FL 33431

Premier Value Infants' Gas Relief (70901pvfc Ol)

Premier Value Infants' Gas Relief (70901pvfc Ol)

Premier Value Infants' Gas Relief

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