Label: ALLI- orlistat capsule
- NDC Code(s): 71610-805-34
- Packager: Aphena Pharma Solutions - Tennessee, LLC
- This is a repackaged label.
- Source NDC Code(s): 0135-0461
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated March 27, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each sealed capsule)
- Purpose
- Use
-
Warnings
Organ transplant alert:
- do not use if you have had an organ transplant. Orlistat interferes with the medicines used to prevent transplant rejection.
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 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
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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.
- Other information
- Inactive ingredients
-
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
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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 - PRINCIPAL DISPLAY PANEL - 60mg
-
INGREDIENTS AND APPEARANCE
ALLI
orlistat capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71610-805(NDC:0135-0461) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ORLISTAT (UNII: 95M8R751W8) (ORLISTAT - UNII:95M8R751W8) ORLISTAT 60 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 2 (UNII: L06K8R7DQK) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) FERROUS OXIDE (UNII: G7036X8B5H) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color turquoise (capsule) , blue (dark blue band) Score no score Shape CAPSULE Size 15mm Flavor Imprint Code Orlistat;60 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71610-805-34 2280 in 1 BOTTLE; Type 0: Not a Combination Product 03/22/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021887 02/07/2007 Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585) Establishment Name Address ID/FEI Business Operations Aphena Pharma Solutions - Tennessee, LLC 128385585 repack(71610-805)
