Mylicon is considered safe for newborns. The active ingredient, simethicone, is not absorbed into the bloodstream. It works entirely within the digestive tract and passes through the body unchanged, making it one of the few over-the-counter remedies appropriate for very young infants. That said, while Mylicon carries minimal risk, the evidence that it actually relieves gas or colic symptoms is weak.
How Simethicone Works
Simethicone is a defoaming agent. When your baby swallows air during feeding or crying, small gas bubbles can get trapped in the stomach and intestines. Simethicone lowers the surface tension of those bubbles, causing them to merge into larger bubbles that are easier for the body to expel through burping or passing gas. It doesn’t reduce gas production or change digestion in any way. It simply makes existing bubbles easier to move out.
Because simethicone never enters the bloodstream, it doesn’t interact with medications, and there’s no risk of it building up in your baby’s system. This is the core reason it has such a strong safety profile, even for newborns.
Dosing for Infants
For babies under 2 years old (and under 24 pounds), the standard dose is 0.3 mL per use. You can give it after feedings and at bedtime, repeating as needed throughout the day, but should not exceed 12 doses in 24 hours. You can place the drops directly into your baby’s mouth using the included dropper, or mix them into a bottle of formula or expressed breast milk.
Always shake the bottle before use and measure carefully with the dropper provided. Generic infant gas drops contain the same active ingredient at the same concentration, so the brand name itself doesn’t matter.
Side Effects Are Rare
Simethicone has essentially no known side effects in infants at recommended doses. The only concern is a possible allergic reaction, which would show up as a skin rash, hives, or swelling of the face, lips, tongue, or throat. This is extremely uncommon. If you notice any of these signs after giving the drops, stop using them and contact your pediatrician.
The inactive ingredients in Mylicon Original include things like sorbitol, citric acid, and flavoring agents. The formula is free of alcohol. If your baby has known sensitivities or allergies, checking the full inactive ingredient list on the package is a reasonable step, but most infants tolerate the drops without any issue.
Does It Actually Work?
This is where the picture gets less reassuring. Despite being widely used by parents, simethicone has not performed well in clinical testing. A systematic review of three randomized controlled trials found that simethicone drops were no better than a placebo at reducing colic symptoms. Parents often report that the drops seem to help, but controlled studies haven’t confirmed that effect.
Part of the problem is that infant fussiness blamed on “gas” may not actually be caused by gas. Children’s Hospital of Philadelphia notes that babies with colic often burp frequently or pass a lot of gas, but this is thought to be a result of swallowing air while crying, not the cause of their distress. So treating the gas may not address the underlying reason your baby is uncomfortable.
Gas vs. Colic: What You’re Seeing
Straightforward gas tends to cause a visibly bloated belly, fussiness that comes and goes (often around feedings), and frequent burping or flatulence. These episodes are usually short-lived and your baby seems comfortable between them.
Colic is a different pattern. It’s typically defined as crying that lasts more than 3 hours per day, more than 3 days per week, in an otherwise healthy baby under 3 months old. Colic episodes often peak in the evening and can be intense, with the baby drawing up their legs and appearing to be in pain. If your baby fits the colic pattern, simethicone may not make a meaningful difference, though it’s unlikely to cause harm either.
Practical Tips Beyond Gas Drops
If your newborn seems gassy, a few techniques can help alongside or instead of simethicone drops. Burping your baby more frequently during feedings, keeping them upright for 15 to 20 minutes after eating, and gently bicycling their legs can all encourage trapped air to move through. For bottle-fed babies, trying a slow-flow nipple or an anti-colic bottle design may reduce the amount of air swallowed during feeding.
For breastfed babies, ensuring a deep latch reduces air intake. Some parents also find that gentle tummy massage in a clockwise direction helps move gas along the intestines. These approaches are free, carry no risk, and address the mechanical cause of gas rather than just the symptoms.