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OTC

Alli

orlistat · Alli is an intestinal lipase inhibitor (over-the-counter) containing orlistat, made by Haleon US Holdings LLC.

Type
Over the counter
Drug class
Intestinal Lipase Inhibitor
Route
Oral
Manufacturers
1
+ 1 repackager labels

for weight loss in overweight adults, 18 years and older, when used along with a reduced-calorie and low-fat diet

Related recalls

FDA drug recalls that name this drug or its active ingredient

All drug recalls

Active ingredients

(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

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.

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.

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

Ever had gallbladder problems kidney disease or kidney stones pancreatitis

Ask a doctor or pharmacist before use

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

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

Pregnancy or breastfeeding

Do not use.

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away.

Other information

Store at 20 - 25 o C (68 - 77 o F) protect drug from excessive light, humidity and temperatures over 30 o C (86 o F)

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

Forms and strengths

From the FDA NDC Directory · 2 product codes

Dosage formStrengthRouteNDCs
Capsule60 mgoral2

Side effect reports to FDA

FDA Adverse Event Reporting System (FAERS), 25,756 reports that list orlistat, data through 07/30/2026

Anyone can report a problem to FDA, and a report does not mean the drug caused the problem. Reports can be duplicated or incomplete, and counts depend on how widely a drug is used. Do not stop or change a medicine because of this list. Talk to your doctor or pharmacist.

Most often reported reactions

  • Drug ineffective4,544
  • Rectal discharge2,433
  • Gastrointestinal disorder2,186
  • Constipation1,992
  • Diarrhea1,960
  • Weight increased1,946
  • Steatorrhea1,649
  • Flatulence1,619
  • Abdominal pain upper1,374
  • Headache1,118

To report a side effect, use FDA MedWatch.

Manufacturers and labels

2 FDA labels · 1 from repackagers

  • Haleon US Holdings LLCShown hereNDA021887 · Label 03/18/2026 · NDC 0135-0461Full label
Repackager labels (1)
  • Aphena Pharma Solutions - Tennessee, LLC03/27/2024

Alli: common questions

What is Alli used for?
for weight loss in overweight adults, 18 years and older, when used along with a reduced-calorie and low-fat diet
Is Alli a prescription drug?
No. Alli is sold over the counter (OTC) without a prescription.
Are there other products with the same active ingredient as Alli?
Yes. Other FDA-listed products with the same active ingredients include Orlistat, Xenical.
Who makes Alli?
Haleon US Holdings LLC lists Alli with the FDA.

Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 03/18/2026 · Label text is shown as published by the manufacturer. Not medical advice

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