{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-06-01", "results": { "skip": 0, "limit": 1, "total": 4 } }, "results": [ { "spl_product_data_elements": [ "ALLI orlistat FD&C BLUE NO. 2 GELATIN, UNSPECIFIED FERROUS OXIDE MICROCRYSTALLINE CELLULOSE POVIDONE, UNSPECIFIED SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A TALC TITANIUM DIOXIDE ORLISTAT ORLISTAT capsule dark blue band Orlistat;60" ], "active_ingredient": [ "Active ingredient (in each sealed capsule) Orlistat 60 mg" ], "purpose": [ "Purpose Weight loss aid" ], "indications_and_usage": [ "Use for weight loss in overweight adults, 18 years and older, when used along with a reduced-calorie and low-fat diet" ], "warnings": [ "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 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. 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": [ "Do not use if you are taking cyclosporine if you have been diagnosed with problems absorbing food if you are not overweight" ], "ask_doctor": [ "Ask a doctor before use if you have ever had gallbladder problems kidney stones pancreatitis" ], "ask_doctor_or_pharmacist": [ "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": [ "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": [ "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. 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_breast_feeding": [ "If pregnant or breast-feeding, do not use." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away." ], "dosage_and_administration": [ "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." ], "dosage_and_administration_table": [ "
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.
" ], "storage_and_handling": [ "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_ingredient": [ "Inactive ingredients FD&C Blue No. 2, edible ink, gelatin, iron oxide, microcrystalline cellulose, povidone, sodium lauryl sulfate, sodium starch glycolate, talc, titanium dioxide" ], "questions": [ "Questions or comments? call toll-free 1-800-671-2554 Additional information The Starter Pack includes: Read Me First brochure Up to 20 day supply (60 capsules) For more information, visit www.myalli.com TAMPER- EVIDENT features for your protection. The package has a security seal on both ends of the carton printed with the GSK logo. 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. 1-800-671-2554 Distributed by: Haleon, Warren, NJ 07059 Trademarks are owned by or licensed to the Haleon group of companies. ©2023 Haleon group of companies or its licensor. Made in India" ], "spl_unclassified_section": [ "REPACKAGING INFORMATION Please reference the HOW SUPPLIED section listed above for a description of drug product's characteristics. This drug product has been received by Aphena Pharma Solutions - Tennessee, LLC in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below: 60mg NDC 71610-805-34, Bottles of 2280 Capsules Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children. Repackaged by: Cookeville,TN 38506 20240327JK Aphena" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 60mg NDC 71610-805 - Orlistat (Alli) 60mg Capsules - Rx Only 71610-805-34" ], "set_id": "14a75092-f910-53df-e063-6294a90acc66", "id": "14a73146-26ef-3d96-e063-6394a90ab4ce", "effective_time": "20240327", "version": "1", "openfda": { "application_number": [ "NDA021887" ], "brand_name": [ "ALLI" ], "generic_name": [ "ORLISTAT" ], "manufacturer_name": [ "Aphena Pharma Solutions - Tennessee, LLC" ], "product_ndc": [ "71610-805" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ORLISTAT" ], "rxcui": [ "692876", "723846" ], "spl_id": [ "14a73146-26ef-3d96-e063-6394a90ab4ce" ], "spl_set_id": [ "14a75092-f910-53df-e063-6294a90acc66" ], "package_ndc": [ "71610-805-34" ], "original_packager_product_ndc": [ "0135-0461" ], "nui": [ "N0000175591", "N0000009916" ], "pharm_class_epc": [ "Intestinal Lipase Inhibitor [EPC]" ], "pharm_class_moa": [ "Lipase Inhibitors [MoA]" ], "unii": [ "95M8R751W8" ] } } ] }