Quick answers
- What is Orlistat used for?
- The Drug Facts label of Alli (Haleon US Holdings LLC) lists these uses: for weight loss in overweight adults, 18 years and older, when used along with a reduced-calorie and low-fat diet.
- Do I need a prescription for Orlistat?
- No, the products on this page are sold without a prescription. Other products with the same active ingredient need a prescription (often a higher strength or another form): see the prescription page.
- Is a store brand the same as the name brand?
- Products listed together below have the same active ingredient, in the same amount and the same form, as registered with the FDA. Inactive ingredients (such as colors, flavors and fillers) and package sizes can differ. Compare the “Active ingredient” box on both packages, and ask a pharmacist if you are not sure.
- Has Orlistat been recalled?
- No recall linked to these products appears in the FDA enforcement reports we use.
Also sold by prescription (often at a higher strength or in another form): Orlistat — prescription medicine
Drug Facts label
Every over-the-counter medicine must carry a “Drug Facts” box in the same order, set by FDA rules. Below is the label of one product for each common strength and form, quoted word for word. Your own package can differ (for example, children’s products have other directions): always follow the label on your package.
Alli · Haleon US Holdings LLC
Orlistat 60 mg, capsule (oral)
Active ingredient (in each sealed capsule)
Orlistat 60 mg
Purpose
Weight loss aid
Uses
for weight loss in overweight adults, 18 years and older, when used along with a reduced-calorie and low-fat diet
Warnings
- Organ transplant alert: do not use if you have had an organ transplant. Orlistat interferes with the medicines used to prevent transplant rejection.
- Allergy alert: do not use if you are allergic to any of the ingredients in orlistat capsules
Do not use
if you are taking cyclosporine if you have been diagnosed with problems absorbing food if you are not overweight
Ask a doctor before use if
you have ever had gallbladder problems kidney disease or kidney stones pancreatitis
Ask a doctor or pharmacist before use if
you are taking any of the following prescription medications. Some prescription doses may need to be adjusted, or some medications may not work as well when used with orlistat. anticoagulants (blood thinning medicine) amiodarone (heart medicine) diabetes medicine thyroid disease medicine seizure medicine antiretrovirals (HIV medicine) taking any other weight loss products
When using this product
take a multivitamin once a day, at bedtime . Orlistat can reduce the absorption of some vitamins. follow a well-balanced, reduced-calorie, low-fat diet. Try starting this diet before taking orlistat. orlistat works by preventing the absorption of some of the fat you eat. The fat passes out of your body, so you may have bowel changes. You may get: gas with oily spotting loose stools more frequent stools that may be hard to control eating a low-fat diet lowers the chance of having these bowel changes for every 5 pounds you lose from diet alone, orlistat can help you lose 2-3 pounds more. In studies, most people lost 5-10 pounds over 6 months.
Stop use and ask a doctor if
you develop itching, yellow eyes or skin, dark urine or loss of appetite. There have been rare reports of liver injury in people taking orlistat. you develop severe pain in the back or groin, painful urination, blood in your urine, swelling of the legs or feet, or are urinating less often than normal. There have been rare reports of kidney injury in people taking orlistat. severe or continuous abdominal pain occurs. This may be a sign of a serious medical condition. you are taking medicine for seizures and your seizures happen more often or get worse
If pregnant or breast-feeding
do not use.
Keep out of reach of children
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
read the enclosed brochure for other important information diet and exercise are the starting points for any weight loss program. Try these first before adding orlistat. Check with your doctor before starting any exercise program. to see if orlistat capsules are right for you, find your height on the chart to the right. You may consider starting a weight loss program with orlistat if your weight is the same or more than the weight shown for your height. for overweight adults 18 years and older: take 1 capsule with each meal containing fat do not take more than 3 capsules daily use with a reduced-calorie, low-fat diet and exercise program until you reach your weight loss goal. Most weight loss occurs in the first 6 months. if you stop taking orlistat, continue with your diet and exercise program if you start to regain weight after you stop taking orlistat, you may need to start taking orlistat again along with your diet and exercise program take a multivitamin once a day, at bedtime, when using orlistat
| Ht. / Wt. | |
| 4’10” | 129 lbs. |
| 4’11” | 133 lbs. |
| 5’0” | 138 lbs. |
| 5’1” | 143 lbs. |
| 5’2” | 147 lbs. |
| 5’3” | 152 lbs. |
| 5’4” | 157 lbs. |
| 5’5” | 162 lbs. |
| 5’6” | 167 lbs. |
| 5’7” | 172 lbs. |
| 5’8” | 177 lbs. |
| 5’9” | 182 lbs. |
| 5’10” | 188 lbs. |
| 5’11” | 193 lbs. |
| 6’0” | 199 lbs. |
| 6’1” | 204 lbs. |
| 6’2” | 210 lbs. |
| 6’3” | 216 lbs. |
| 6’4” | 221 lbs. |
| 6’5” | 227 lbs. |
Inactive ingredients
edible ink, FD&C blue no. 2, gelatin, iron oxide, microcrystalline cellulose, povidone, sodium lauryl sulfate, sodium starch glycolate, talc, titanium dioxide
Questions?
1-800-452-0051 Additional information TAMPER- EVIDENT features for your protection. The package has a security seal on both ends of the carton. The bottle of capsules has a foil seal under the cap imprinted with the words “sealed for your protection”. Each individual capsule is sealed with a dark blue band around the center of the capsule. DO NOT USE THIS PRODUCT IF ANY OF THESE TAMPER-EVIDENT FEATURES ARE MISSING, TORN OR BROKEN. For more information and to learn more about alli, visit us at www.my alli .com The Starter Pack includes: Read Me First brochure Up to 20 day supply (60 capsules) For more information, visit www.myalli.com
— FDA label of Alli, Haleon US Holdings LLC, effective March 18, 2026. See the official label on DailyMed →
This page is not medical advice. Read the label on your package, and ask a pharmacist or doctor if you are not sure a medicine is right for you, for your child, or with your other medicines.
Same medicine, other brands
Each group lists the products that have exactly the same active ingredient, in the same amount and form, as registered with the FDA (NDC Directory). A store brand in the same group has the same medicine as the name brand; inactive ingredients, flavors and package sizes can differ. Each product links to its own official label.
Orlistat 60 mg · capsule (oral) · 2 products
Drug Facts for this strength and form ↑
| Brand or product name | Company on the label | Label |
|---|---|---|
| Alli | Aphena Pharma Solutions - Tennessee, LLC | DailyMed |
| Alli | Haleon US Holdings LLC | DailyMed |
Companies that sell this medicine
The company named on the package (maker or distributor), as listed in the FDA NDC Directory, with its number of over-the-counter products of this medicine.
- Haleon US Holdings LLC1 product
- Aphena Pharma Solutions - Tennessee, LLC1 product
Recalls
No recall linked to these products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- FDA rule for the Drug Facts label (21 CFR 201.66)
Only medicines marketed under FDA rules for nonprescription drugs (an FDA monograph or an FDA approval) are listed. Homeopathic products are not listed: the FDA does not evaluate them for safety or effectiveness.