ALLI

Dosage form: capsule
Ingredients: ORLISTAT 60mg
Labeler: GlaxoSmithKline Consumer Healthcare LP
NDC Code: 0135-0461

Drug Facts

Active ingredient (in each sealed capsule)

Orlistat 60 mg

Purpose

Weight loss aid

Use
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 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.

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

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 and 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)

The Refill Pack includes:

Read Me First brochure
Up to 40 day supply (120 capsules)

For more information, visit www.Myalli.com

How is this Refill Pack different than the Starter Pack?

IF THIS IS YOUR FIRST alli PROGRAM PURCHASE, YOU NEED TO BUY THE STARTER PACK. This refill pack is designed for people who are already using alli and have previously purchased the Starter Pack.

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.

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.

alli, Myalli.com, MyalliPlan.com, alli Shuttle and various design elements are trademarks of the GlaxoSmithKline group of companies.

Distributed by:

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108 Made in India

US Patent No. 6,004,996

Principal Display Panel

NDC 0135-0461-05

alli®

Orlistat 60mg Capsules

Weight Loss Aid

FDA approved

non-prescription

weight loss aid

Helps you lose more weight than dieting alone

120 CAPSULES

Refill Pack

SEE SIDE OF PACKAGE FOR LISTING OF CONTENTS

©2012 GlaxoSmithKline

100782XC

ALLI 
orlistat capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0461
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ORLISTAT (ORLISTAT) ORLISTAT60 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 2 
GELATIN 
FERROUS OXIDE 
CELLULOSE, MICROCRYSTALLINE 
POVIDONES 
SODIUM LAURYL SULFATE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorTURQUOISE (capsule) , BLUE (dark blue band) Scoreno score
ShapeCAPSULESize15mm
FlavorImprint CodeOrlistat;60
Contains    
Packaging
#Item CodePackage Description
1NDC:0135-0461-0290 CAPSULE in 1 BOTTLE
2NDC:0135-0461-03120 CAPSULE in 1 BOTTLE
3NDC:0135-0461-05120 CAPSULE in 1 BOTTLE
4NDC:0135-0461-06170 CAPSULE in 1 BOTTLE
5NDC:0135-0461-0721 CAPSULE in 1 BOTTLE
6NDC:0135-0461-082 BOTTLE in 1 CARTON
660 CAPSULE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02188702/07/2007
Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)

Revised: 08/2013
 
GlaxoSmithKline Consumer Healthcare LP

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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