Infants Suspension/ Drops
FDA Label NDC 0536-1303

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rugby Laboratories for the product Infants (NDC 0536-1303). 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?, 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)

→ Purpose

→ Uses

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel

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
▪find right dose on chart below. If possible, use weight to dose; otherwise, use age.
▪only use the enclosed syringe. Do not use other syringe, dropper, spoon or dosing device when giving this medicine to your child.
▪remove cap and insert syringe into the bottle.
▪pull syringe up until filled to the prescribed level, simply push syringe back until you have reached the described level. Slowly dispense the liquid into your child’s mouth (towards inner cheek).
▪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.
▪dosage can also be mixed with 1 oz. cool water, infant formula or other suitable liquids.
▪Replace cap tightly to maintain child resistance
▪mL = milliliter

Age (yr)	Weight (lb)	Dose (mL)
infants under 2	under 24	0.3
children over 2	over 24	0.6

Other Information

▪tamper evident: do not use if printed seal under cap is broken or missing
▪Store at room temperature
▪do not freeze
▪see bottom panel for lot number and expiration date

Inactive Ingredients

carboxymethylcellulose sodium, citric acid, flavors, microcrystalline cellulose, polysorbate 60, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol, xanthan gum