Infants Gas Relief
FDA Label NDC 17856-5894

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 Corps for the product Infants Gas Relief (NDC 17856-5894). 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, use, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Purpose

Antigas

Warnings


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 inner cheek
  • dosage can also be mixed with 1 oz. of cool water, infant formula or other suitable liquids
  • clean dropper well after each use and replace original cap

    • 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 foil seal under cap is broken or missing.
  • store at room temperature
  • do not freeze
  • see bottom panel for lot number and expiration date

How Supplied

Product: 17856-5894

NDC: 17856-5894-1 10 mL in a CUP

NDC: 17856-5894-4 1.2 mL in a DOSE PACK / 60 in a CASE

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