Sunmark Infants Gas Relief Drops
FDA Label NDC 49348-577

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 Infants Gas Relief Drops (NDC 49348-577). 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, warnings, when using this product, keep out of the reach of children., 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)

→ Purpose

→ Uses

→ Warnings

→ When Using This Product

→ Keep Out Of The Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Principal Display Panel

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

Warnings

When Using This Product

do not exceed 12 doses per day

Keep Out Of The Reach Of Children.

Directions

shake well before using
all dosages may be repeated as needed, after meals and at bedtime
fill enclosed dropper to recommended 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 replace original cap.
age (yr)   weight (lb)
dose
infants under 2
under 24   0.3 mL
children over 2
over 24   0.6 mL