On this page
Aleve’s labels list no wheat, barley or rye ingredient and Bayer says it adds no gluten, but Bayer can’t guarantee Aleve is 100% gluten-free, and its newer caplets and tablets add two ingredients that can be made from starch without naming the plant.
It depends on the formula and on how sensitive you are. None of Bayer’s current Aleve labels on DailyMed names a gluten-containing grain, and Bayer says it doesn’t add gluten, but it can’t guarantee Aleve is 100% gluten-free because it’s made in a facility that also handles items that may contain gluten. The original caplets and tablets list no starch at all; a newer formula of Aleve caplets, tablets, Back & Muscle Pain and Headache Pain lists sodium starch glycolate and mannitol, with no source named. Ask a pharmacist or call Bayer at the number on the box if you need more.
Aleve is one of the pain relievers readers ask us about most, so we re-checked this page against every current Aleve label on DailyMed. The short version: no Aleve label names wheat, barley or rye, and none says “gluten-free.” Bayer says it adds no gluten but won’t promise Aleve is gluten-free because of a shared facility. It also currently lists two formulas of Aleve caplets and tablets, and the newer one adds two ingredients whose source the label doesn’t give.
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 Bayer Says About Gluten in Aleve
Bayer makes Aleve. None of its current Aleve labels on DailyMed, the National Library of Medicine’s free label database, mentions gluten, wheat, barley, rye or malt. None of them uses the FDA’s suggested voluntary wording for medicines either: “Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).” So the label tells you what’s in the product, but not where every ingredient came from.
Bayer’s Aleve FAQ adds that it doesn’t add gluten to its products, but can’t guarantee they’re 100% gluten-free because they’re made in a facility that also handles items that may contain gluten.
What’s in Aleve, Form by Form
The inactive ingredients below come from Bayer’s current Aleve labels on DailyMed. None of them names wheat, barley, rye or malt.
- Aleve Caplets and Tablets, original formula: no starch. The list is FD&C blue #2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc and titanium dioxide (DailyMed label).
- Aleve Caplets and Tablets, newer formula: a different list that includes mannitol and sodium starch glycolate, plus colloidal silicon dioxide and stearic acid. DailyMed’s coded ingredient table lists the sodium starch glycolate as “sodium carboxymethyl starch,” with no plant named (DailyMed label). The newer Back & Muscle Pain and Headache Pain labels use the same list.
- Aleve Gelcaps: no starch. The coating contains gelatin, and the list includes glycerin and edetate disodium.
- Aleve Liquid Gels: no starch. The capsule contains gelatin, and the list includes mannitol and sorbitol, sugar alcohols whose source the label doesn’t name (DailyMed label). An older Liquid Gels label lists a slightly different set of ingredients.
- Aleve PM: no starch. It pairs naproxen with diphenhydramine, the active ingredient in Benadryl, and its inactive list is the original Aleve list plus carnauba wax and purified water.
- Aleve-D Sinus & Cold and Sinus & Headache: no starch, but both list lactose monohydrate.
What the FDA Says About Gluten in Medicines
Medicines aren’t covered by the gluten-free labeling rule for food, and the FDA has never set a standard for calling a drug gluten-free. Here’s what its Medications and Gluten page and its draft guidance on gluten in drugs say, and what it means for Aleve:
- 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.
- Starch names don’t tell you the plant: plain wheat starch has to be called “wheat starch,” but ingredients made from starch, like the sodium starch glycolate and mannitol in newer Aleve, don’t have to name their source. The FDA says other starches, such as corn and potato, are more commonly used in medicines.
- No “Contains: Wheat” rule for drugs: the food allergen law behind that line doesn’t apply to over-the-counter drugs, according to the FDA’s allergen labeling guidance. A missing allergen line on a medicine box tells you nothing.
The FDA adds that if a medicine’s ingredient list doesn’t mention wheat gluten or wheat flour, the product shouldn’t contain gluten in an amount that would harm a typical (non-refractory) person with celiac disease. People who react to very small amounts may still want to know where a starch came from, and the label alone can’t tell them.
Cross-Contamination Risk
- No current Aleve label names wheat, barley, rye or malt.
- Bayer says it adds no gluten, but Aleve is made in a facility that also handles items that may contain gluten.
- Newer caplets and tablets list sodium starch glycolate and mannitol with no source named.
- Store-brand naproxen 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 Aleve You Bought
- Read the Drug Facts on your box: the “Inactive ingredients” line tells you which formula you have. Sodium starch glycolate and mannitol mean the newer one.
- Look it up on DailyMed: search the NDC number printed on 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 Bayer: the number under “Questions or comments?” on the Drug Facts label reaches the maker. Ask where the sodium starch glycolate and mannitol come from, and what its shared-facility note means for the product you take.
Frequently Asked Questions
Is Aleve gluten-free?
Aleve isn’t labeled gluten-free, and the FDA has no gluten-free standard for medicines. Bayer says it doesn’t add gluten to Aleve, but can’t guarantee it’s 100% gluten-free because it’s made in a facility that also handles items that may contain gluten. Bayer’s current Aleve labels on DailyMed list no wheat, barley or rye ingredient. The original caplets and tablets list no starch, but a newer formula adds sodium starch glycolate and mannitol with no source named, so check the inactive ingredients on your box and ask a pharmacist if you need to know more.
Are Aleve Liquid Gels gluten-free?
Aleve Liquid Gels list no starch and no gluten-containing grain on their current DailyMed label. The capsule contains gelatin, and the list includes mannitol and sorbitol, sugar alcohols that can be made from starch and whose source the label doesn’t name. They aren’t labeled gluten-free.
Is Aleve PM gluten-free?
Aleve PM isn’t labeled gluten-free. Its current DailyMed label lists no starch and no gluten-containing grain. It combines naproxen with diphenhydramine, and its inactive ingredients are the original Aleve list plus carnauba wax and purified water.
Is generic naproxen gluten-free?
Store-brand naproxen has the same active ingredient as Aleve, but each maker picks its own inactive ingredients. Read the Drug Facts on the store-brand box, or look up its NDC number on DailyMed, before you swap. A gluten statement on a medicine box is voluntary, and the FDA hasn’t set a standard for one.
Why isn’t Aleve 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, “Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye),” but that guidance is still a draft, and Aleve’s labels don’t use it. Bayer also says it can’t guarantee Aleve is 100% gluten-free, because Aleve is made in a facility that handles items that may contain gluten.
Would the label say “wheat” if Aleve had a wheat-derived ingredient?
Not necessarily. Plain wheat starch must be listed as “wheat starch,” but ingredients made from starch, like sodium starch glycolate and mannitol, don’t have to name the plant they came from. And the “Contains: Wheat” allergen line is a food rule that doesn’t apply to over-the-counter drugs. The FDA’s high estimate for gluten from a wheat-derived drug ingredient is under 0.5 mg per dose.