No, Hyland’s colic tablets aren’t proven safe for newborns; labels say “0 months+,” but they’re unapproved and evidence for relief is weak.
New parents hunt for anything that might soothe a gassy, crying baby. Homeopathic colic tablets often pop up in that search. Labels can look reassuring, and the pills melt in the mouth. Still, newborns have special risks, and the science behind these tablets is thin. This guide lays out what the product is, what the label and regulators say, what research shows, and which steps are safer to try first in the earliest weeks.
What These Tablets Are And How They’re Marketed
Hyland’s sells quick-dissolving pellets that claim relief of fussiness, gas pain, and cramping. The active ingredients are homeopathic dilutions of chamomile, colocynth, and wild yam, mixed with lactose and acacia. Packages and third-party listings have shown “Ages 0 months+,” along with dosing directions for babies and toddlers. The bottles also carry a disclosure that they’re homeopathic and not evaluated like regular over-the-counter drugs.
Are Homeopathic Colic Tablets Safe For A Newborn? Label Vs. Oversight
Here’s where confusion starts. A label can say “0 months+,” but that does not mean a product has been reviewed for newborn safety the same way as approved medicines. Homeopathic baby products are sold in the U.S. without pre-market evaluation for safety or effectiveness. That gap matters most in the first month of life, when small dosing errors, hidden contaminants, or mismatched ingredients can hit far harder.
How The Label Reads
Typical homeopathic directions advise melting two tiny tablets on the tongue at short intervals, then spacing out doses once symptoms ease. The same label lists the three homeopathic actives and two inactive ingredients. You’ll also see “unapproved homeopathic” in the fine print and, in some versions, the “0 months+” age badge.
What Regulators Have Flagged In Similar Products
U.S. regulators have warned parents about safety problems with other baby homeopathic tablets in the past. Teething tablets from several brands were pulled after the agency found inconsistent levels of plant alkaloids and tied the products to reports of serious events. While those were teething items—not the colic formula—the episode showed how little independent oversight homeopathic baby tablets may receive before they reach a nursery.
Evidence Check: Do These Tablets Help Colic?
Colic usually peaks around six weeks and fades by three to four months. Trials on pain-relief approaches for colic are mixed and often small. Reviews of treatments have not found solid, repeatable benefits for common “soothers” like simethicone drops, and the data for homeopathic blends are sparse. When parents do see calmer nights, the improvement may reflect the natural course of colic, feeding fixes, or simple time and cuddling.
What The Research Says In Plain Terms
- High-quality reviews find insufficient proof that homeopathic pain-relief options help colic.
- Simethicone, another popular option, hasn’t shown consistent benefit for crying time.
- Probiotic use has mixed findings by strain and feeding method; it isn’t a newborn quick fix.
Early Snapshot Table: What Parents Try For Colic (And What We Know)
This broad table sits near the top so you can compare common choices at a glance.
| Option | What The Evidence Shows | Newborn (0–28 Days) Notes |
|---|---|---|
| Homeopathic colic tablets | Insufficient proof of benefit across reviews; sold as unapproved homeopathic remedies. | Labeling may say “0 months+,” but there’s no pre-market safety review; avoid in the first month. |
| Simethicone drops | No clear reduction in colic crying time in controlled trials. | If used, dosing must match weight/age; not a first-line newborn fix. |
| Probiotics (strain-specific) | Mixed results; some benefit shown in breastfed infants with a single strain in later weeks. | Not for use without guidance in the first month; strain and product selection matter. |
| Feeding and burping tweaks | Can reduce swallowed air and gas; practical, low-risk steps. | Safe from day one when done gently and correctly. |
| Holding, swaddling, motion, white noise | Common soothing strategies; evidence is experiential but widely recommended. | Use safe swaddling and safe-sleep rules; fine for newborns when done correctly. |
Ingredient Look: What’s Inside The Tablets
The three homeopathic actives are:
- Chamomilla 6X — marketed for irritability.
- Colocynthis 6X — marketed for gas cramps.
- Dioscorea 6X — marketed for colicky pain eased by movement.
Inactive ingredients commonly include lactose and acacia. Lactose is tiny per pellet, yet babies with suspected lactose overload from feeding patterns won’t benefit from extra sugar tablets. The bigger issue isn’t these specific substances at the labeled dilutions; it’s the lack of independent confirmation that every bottle matches every claim, batch after batch, especially for the youngest infants.
Why Newborns Are Different
In the first month, even small dosing mistakes can matter. Newborn airways are tiny, and while these pellets dissolve, a frantic dose during a crying spell can still go sideways. Their gut, liver, and kidneys are immature. Any product that hasn’t been checked for newborn safety can stack risk without a reliable upside. For that reason, many pediatric clinicians steer families to non-drug measures first and to talk with their doctor before trying any drops or tablets in the first weeks.
What Safer First Steps Look Like
Before reaching for a bottle of pellets, try steps that lower swallowed air and ease tight bellies. These can be started from day one.
Feeding Tweaks That Help
- Slow the feed. Use paced-bottle techniques or adjust breast-side timing so your baby isn’t gulping and gassy.
- Keep the nipple full of milk. Tilt the bottle so less air gets in; check for a steady, not gush-y, flow.
- Frequent burps. Stop midway and at the end; try over-shoulder, sitting-up, and tummy-down positions.
Soothing That’s Gentle And Safe
- Hold and rock. Upright cuddling after feeds can settle gas pockets.
- Warm bath or tummy massage. Small clockwise circles can relax a tight belly.
- White noise and swaddling. Swaddle snug at the chest with hips free, and always place baby on the back to sleep.
Where Medical Advice Fits In
Crying that won’t let up, poor feeding, fever, a swollen belly, green or bloody stools, or a baby who’s hard to wake is not typical colic. That needs same-day care. If you’re unsure, call your pediatric clinic and describe the symptoms. You can also ask about weight checks, feeding assessment, and whether any drops or probiotics make sense later on for your baby’s specific situation.
Regulatory Context Parents Should Know
Homeopathic remedies occupy a special category in the U.S. They’re listed in the Homeopathic Pharmacopoeia and can be marketed without the same pre-market proof as conventional drugs. In baby products, that gap has mattered. After reports tied teething tablets to serious events, federal authorities urged parents to stop using them and companies removed them from shelves. This was a different product line, but it shows why parents should be careful with any unapproved baby tablet, especially in the first month.
How We Judged Safety And Benefit Here
This piece weighs three things: what the product label claims, what regulators have said about similar products, and what independent evidence shows about colic relief. Labels can be permissive, but newborn care should be conservative. When benefits aren’t clear and oversight is light, the balance tilts away from products that go in a newborn’s mouth.
Mid-Article Fact Check Links
To read the federal safety notice on baby homeopathic tablets, see the FDA warning on homeopathic teething tablets. For practical calming steps and what usually helps, see the American Academy of Pediatrics’ parent page on colic relief tips.
Later-Stage Table: Label Facts, Ingredients, And What They Mean
Use this to decode the package and decide if the product deserves a spot in your diaper bag.
| Label Item | What It Says | What That Means For Newborns |
|---|---|---|
| Age range | “0 months+” and directions for small babies | This is a marketing claim, not proof of newborn safety testing. |
| Regulatory status | “Unapproved homeopathic” with HPUS actives | No pre-market review for safety or effectiveness; caution in the first month. |
| Active ingredients | Chamomilla 6X, Colocynthis 6X, Dioscorea 6X | Homeopathic dilutions; claimed benefits aren’t backed by strong trials. |
| Inactive ingredients | Lactose, acacia | Small amounts; not a fix for feeding-related lactose overload. |
| Dosing style | Frequent tiny pellets that melt on the tongue | Even melt-away pellets add handling and dosing steps during intense crying. |
Practical Path If You’re In The Thick Of It
- Rule out red flags. Any fever, bile-stained vomit, blood in stool, poor feeding, or lethargy needs same-day care.
- Fix the feed first. Pace the bottle, check latch, burp often, and check the nipple flow rate.
- Track patterns for a week. Note time of day, feed volumes, stools, and soothing tricks that actually work.
- Ask about next steps at your clinic. If crying stays intense after the first weeks, your pediatric team can review feeding, weight gain, and whether any trial (like a specific probiotic later on) makes sense.
- Skip unproven tablets in the first month. The risk-benefit tradeoff doesn’t favor a newborn.
Bottom Line For Tired Parents
Labels on homeopathic colic tablets can look newborn-friendly, yet there’s no solid proof they help, and they’re sold without the review parents expect for infant medicines. In the early weeks, the safer path is hands-on soothing, feeding fixes, and a quick call to your clinic when something feels off. Save experimental tablets for later—if at all—and only after you’ve talked it through with your pediatric team.