Label: ALLI- orlistat capsule
Contains inactivated NDC Code(s)
NDC Code(s): 0135-0461-01, 0135-0461-02, 0135-0461-03, 0135-0461-05, view more0135-0461-06, 0135-0461-07, 0135-0461-08
- Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated April 19, 2018
If you are a consumer or patient please visit this version.
- Active ingredient (in each sealed capsule)
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
- 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.
- Other information
- Inactive ingredients
Questions or comments?
call toll-free 1-800-671-2554
The Starter Pack includes:
- Read Me First brochure
- Convenient Carrying Case
- 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.myalli.com.
Trademarks are owned by or licensed to the GSK group of companies.
GSK Consumer Healthcare
Warren, NJ 07059 Made in India
©2015 GSK group of companies or its licensor. All rights reserved.
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INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) 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 POTATO (UNII: 5856J3G2A2) 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:0135-0461-02 90 in 1 BOTTLE; Type 0: Not a Combination Product 02/07/2007 2 NDC:0135-0461-03 120 in 1 BOTTLE; Type 0: Not a Combination Product 02/07/2007 3 NDC:0135-0461-05 120 in 1 BOTTLE; Type 0: Not a Combination Product 02/07/2007 4 NDC:0135-0461-06 170 in 1 BOTTLE; Type 0: Not a Combination Product 02/07/2007 5 NDC:0135-0461-07 21 in 1 BOTTLE; Type 0: Not a Combination Product 02/07/2007 6 NDC:0135-0461-08 2 in 1 CARTON 02/07/2007 6 60 in 1 BOTTLE; Type 0: Not a Combination Product 7 NDC:0135-0461-01 60 in 1 BOTTLE; Type 0: Not a Combination Product 09/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021887 02/07/2007 Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)