Infants Gas Relief Drops
FDA Label NDC 15127-042

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Select Brand for the product Infants Gas Relief Drops (NDC 15127-042). 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, otc - keep out of reach of children, warnings, when using this product, directions, other information, 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 of gas frequently caused by air swallowing or certain formulas or foods

Otc - Keep Out Of Reach Of Children


Warnings


When Using This Product

do not exceed 12 doses per day

Keep out of reach of children. In case of overdose get medical help or contact a poison control center immediately.

Directions

  • shake well before using
  • all dosages may be repeated as needed, after meals and at bedtime
  • fill enclosed dropper to recommend dosage level
  • dispense liquid slowly into baby's mouth, toward the inner cheek
  • may mix with 1 oz. of cool water, infant formula or other suitable liquids
  • clean dropper after each use and close the bottle to maintain child resistance

    • age (yr)
    		weight (lb)
    		dose
    infants under2
    		under 24
    		0.3 mL
    children over 2
    		over 24
    		0.6 mL

Other Information

store at room temperature

Inactive Ingredients

benzoic acid, flavor, magnesium aluminum silicate, purified water, simethicone emulsion, sorbitol, xanthan gum

Principal Display Panel

Select Brand

Compare to the active ingredient in Infants Mylicon® Drops

Infant's Gas Relief Drops

Simethicone

Anti-Gas

Non-staining

Excess Gas relief

Alcohol Free

Saccharin Free

No Artificial Flaovr


1 fl oz (30 mL)

Box (Sb520b)

Box (Sb520b)

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