Generic Name: orlistat
Dosage Form: capsule - Drug Facts

Drug Facts

Active ingredient (in each sealed capsule)

Orlistat 60 mg

Purpose

Weight loss aid

Slideshow: Newly Approved Weight Loss Drugs: Can They Help You?

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 stones
  • pancreatitis

Ask a doctor or pharmacist before use if you are

  • taking warfarin (blood thinning medicine), or taking medicine for diabetes or thyroid disease. Your medication dose may need to be adjusted.
  • taking 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 chances 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

severe or continuous abdominal pain occurs. This may be a sign of a serious medical condition.

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
Height / Weight 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.

Other information

  • store at 20 - 25oC (68 - 77oF)
  • protect drug from excessive light, humidity ad temperatures over 30oC (86oF)

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 or comments?

Call toll-free 1-800-671-2554 (English/Spanish) weekdays (10:00am - 4:30pm EST)

For more information and to learn more about Alli, visit us at www.MyAlli.com.

To get information in Spanish, please call toll-free 1-877-469-2554.

TAMPER- EVIDENT features for your protection. 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.

Alli, MyAlli.com, MyAlliPlan.com, Alli Shuttle and various design elements are trademarks of GlaxoSmithKline.

Distributed by:

GlaxoSmithKline

Consumer Healthcare, L.P.

Moon Township, PA 15108

US Patent Nos. 4,598,089

6,004,996

Shuttle Patent Pending

© 2007 GlaxoSmithKline

Principal Display Panel

AlliTM

Orlistat 60 mg Capsules

Weight Loss Aid

FDA approved

non-prescription

weight loss aid

Helps you lose more weight than dieting alone

150 CAPSULES

For more information, visit www.MyAlli.com

STARTER PACK

SEE TOP OF PACKAGE FOR LISTING OF CONTENTS

The Starter Pack includes:

  • Read Me First brochure
  • Convenient Carrying Case
  • Up to 50 day supply (150 capsules)

 

Alli 
orlistat capsule
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0461
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ORLISTAT (ORLISTAT) ORLISTAT 60 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 2  
GELATIN  
CELLULOSE, MICROCRYSTAlliNE  
POVIDONE  
SODIUM LAURYL SULFATE  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
TALC  
TITANIUM DIOXIDE  
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
1 NDC:0135-0461-01 60 CAPSULE (CAPSULE) in 1 BOTTLE
2 NDC:0135-0461-02 90 CAPSULE (CAPSULE) in 1 BOTTLE
3 NDC:0135-0461-03 120 CAPSULE (CAPSULE) in 1 BOTTLE
4 NDC:0135-0461-04 150 CAPSULE (CAPSULE) in 1 BOTTLE
5 NDC:0135-0461-05 120 CAPSULE (CAPSULE) in 1 BOTTLE
6 NDC:0135-0461-06 170 CAPSULE (CAPSULE) in 1 BOTTLE
7 NDC:0135-0461-07 21 CAPSULE (CAPSULE) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021887 02/07/2007
Labeler - GlaxoSmithKline Consumer Healthcare LP (091328625)
Revised: 08/2010
 
GlaxoSmithKline Consumer Healthcare LP



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