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Tylenol’s labels list no wheat, barley or rye ingredient, but Tylenol isn’t labeled gluten-free, Kenvue makes no gluten statement, and some versions list starches with no source named.
It depends on the version. The current DailyMed labels for Tylenol list no gluten-containing grain, but Extra Strength caplets list pregelatinized starch and sodium starch glycolate without saying what plant they come from, and we found no gluten statement for any Tylenol medicine on Kenvue’s site. Extra Strength Liquid Gels and Children’s Tylenol Dye-Free liquid list no starch at all.
Tylenol (acetaminophen) is the other pain reliever people with celiac disease ask about most, so we re-checked this page against the current Tylenol labels on DailyMed and Kenvue’s own site. An earlier version of this page said Kenvue confirms the starches in Tylenol are corn. We couldn’t find that statement anywhere, so it’s gone. Here’s what the labels actually show.
Check your medicine cabinet for gluten
Fifteen common over-the-counter medicines, what each label shows, what to check on the box, and one question to ask your pharmacist. Plus how to check any medicine yourself. You'll also be first to hear when the LGGF scanner app launches.
What Kenvue Says About Gluten in Tylenol
Kenvue makes Tylenol, and it doesn’t say anything about gluten for its Tylenol medicines. The Tylenol Extra Strength Caplets page lists the inactive ingredients with no gluten statement and no source for the starches. The page we cited in May no longer exists.
What’s in Tylenol, Version by Version
There’s more than one Tylenol Extra Strength caplet on shelves, and their ingredient lists differ. These come from the current Kenvue labels on DailyMed; none of them names wheat, barley, rye or malt.
- Extra Strength caplets, one formula: list pregelatinized starch and sodium starch glycolate. The label’s coded ingredient table names no plant source for either (DailyMed label, NDC 50580-378).
- Extra Strength caplets, another formula: list corn starch, modified starch, pregelatinized starch and sodium starch glycolate, marked “contains one or more of these ingredients.” Only the corn starch has a source (DailyMed label, NDC 50580-449). This is the list tylenol.com shows.
- Extra Strength Liquid Gels: no starch. They list gelatin, glycerin, lecithin and sorbitol, among others.
- Children’s Tylenol Oral Suspension, Dye-Free: no starch. It lists sorbitol solution, sucrose and xanthan gum, among others, and its label doesn’t mention gluten.
The NDC number on your box tells you which formula you have. Other Tylenol products, like PM and cold medicines, have their own lists, so look each one up separately.
What the FDA Says About Gluten in Medicines
The FDA’s gluten-free labeling rule is for food, and the agency has never set a standard for calling a drug gluten-free. Its Medications and Gluten page and draft guidance on gluten in drugs explain why the Tylenol caplet labels can’t settle the starch question by themselves:
- Derived starches don’t name their plant: pregelatinized starch, modified starch and sodium starch glycolate are all made from starch, and their names on a drug label never include the source. Only plain wheat starch must say “wheat starch.” The FDA says the starch used is often corn or potato.
- No added wheat gluten: the FDA knows of no oral drug sold in the US with wheat gluten or wheat flour added as an inactive ingredient.
- A small worst case: in the very rare drug that has a wheat-derived ingredient, the FDA’s high estimate is no more than 0.5 mg of gluten per dose.
- No “Contains: Wheat” rule for drugs: the food allergen law behind that line doesn’t apply to over-the-counter drugs, per the FDA’s allergen labeling guidance. An earlier version of this page said otherwise; that was wrong.
The FDA also says that when a medicine’s ingredient list doesn’t mention wheat gluten or wheat flour, it shouldn’t contain gluten in an amount that would harm a typical (non-refractory) person with celiac disease. If you react to very small amounts, the starch source is still worth asking about.
Cross-Contamination Risk
- No current Tylenol label names wheat, barley, rye or malt.
- Kenvue makes no gluten statement and names no source for the caplets’ starches.
- Store-brand acetaminophen has its own inactive ingredients. Compare its Drug Facts before you swap.
- Keep the box. Its NDC number finds the exact label on DailyMed.
How to Check the Tylenol You Bought
- Read the Drug Facts on your box: check the “Inactive ingredients” line on the package you actually bought.
- Look it up on DailyMed: search the NDC number from the box at dailymed.nlm.nih.gov to find the exact label.
- Ask your pharmacist: the NIH’s digestive diseases institute tells people with celiac disease to ask a pharmacist about ingredients in over-the-counter medicines.
- Call Kenvue: the number under “Questions or comments?” on the Drug Facts label reaches the maker. Ask where the pregelatinized starch and sodium starch glycolate come from.
Frequently Asked Questions
Is Tylenol gluten-free?
Tylenol isn’t labeled gluten-free, and the FDA has no gluten-free standard for medicines. The current Tylenol labels on DailyMed list no wheat, barley or rye ingredient, but Extra Strength caplets list pregelatinized starch and sodium starch glycolate with no source named, and Kenvue makes no gluten statement. Check your box’s label, and ask a pharmacist if you need the starch source.
Is Children’s Tylenol gluten-free?
Children’s Tylenol Oral Suspension, Dye-Free lists no starch and no gluten-containing grain on its current DailyMed label, and its label doesn’t mention gluten. Other children’s versions have their own ingredient lists, so check the one you buy.
Are Tylenol Liquid Gels gluten-free?
Tylenol Extra Strength Liquid Gels list no starch and no gluten-containing grain on their current DailyMed label. They contain gelatin, glycerin, lecithin and sorbitol, among other ingredients. They aren’t labeled gluten-free.
Does Kenvue say the starch in Tylenol comes from corn?
Not that we can find. An earlier version of this page said so, but neither Kenvue’s site nor the DailyMed labels name the source of the pregelatinized starch or sodium starch glycolate in Tylenol Extra Strength caplets. One caplet formula also lists corn starch, which is named as corn.
Is store-brand acetaminophen the same as Tylenol?
The active ingredient is the same, but each maker chooses its own inactive ingredients. Compare the inactive ingredients on the store-brand box, or look up its NDC number on DailyMed, before you switch.
Why isn’t Tylenol labeled gluten-free?
No US law requires a medicine to say whether it contains gluten, and the FDA’s gluten-free labeling rule only covers food. The FDA has suggested voluntary wording for drug labels, but that guidance is still a draft, and Tylenol’s labels don’t use it.