Thursday, October 20, 2016

Alli



orlistat

Dosage Form: capsule - Drug Facts
Drug Facts

Active ingredient (in each sealed capsule)


Orlistat 60 mg



Purpose


Weight loss aid



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 TypeHUMAN OTC DRUGNDC Product Code (Source)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 
CELLULOSE, MICROCRYSTAlliNE 
POVIDONE 
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
#NDCPackage DescriptionMultilevel Packaging
10135-0461-0160 CAPSULE In 1 BOTTLENone
20135-0461-0290 CAPSULE In 1 BOTTLENone
30135-0461-03120 CAPSULE In 1 BOTTLENone
40135-0461-04150 CAPSULE In 1 BOTTLENone
50135-0461-05120 CAPSULE In 1 BOTTLENone
60135-0461-06170 CAPSULE In 1 BOTTLENone
70135-0461-0721 CAPSULE In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02188702/07/2007


Labeler - GlaxoSmithKline Consumer Healthcare LP (091328625)
Revised: 08/2010GlaxoSmithKline Consumer Healthcare LP




More Alli resources


  • Alli Side Effects (in more detail)
  • Alli Dosage
  • Alli Use in Pregnancy & Breastfeeding
  • Alli Drug Interactions
  • Alli Support Group
  • 15 Reviews for Alli - Add your own review/rating


  • Alli MedFacts Consumer Leaflet (Wolters Kluwer)

  • Alli Advanced Consumer (Micromedex) - Includes Dosage Information

  • Orlistat Monograph (AHFS DI)

  • Orlistat Professional Patient Advice (Wolters Kluwer)

  • Orlistat MedFacts Consumer Leaflet (Wolters Kluwer)

  • Xenical Consumer Overview

  • alli Consumer Overview



Compare Alli with other medications


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