ALLI- orlistat capsule 
Aphena Pharma Solutions - Tennessee, LLC

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Drug Facts

Active ingredient (in each sealed capsule)

Orlistat 60 mg

Purpose

Weight loss aid

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.

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 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

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

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

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

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

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:
Aphena
Cookeville,TN 38506

20240327JK

PRINCIPAL DISPLAY PANEL - 60mg

NDC 71610-805 - Orlistat (Alli) 60mg Capsules - Rx Only

71610-805-34

ALLI 
orlistat capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71610-805(NDC:0135-0461)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ORLISTAT (UNII: 95M8R751W8) (ORLISTAT - UNII:95M8R751W8) ORLISTAT60 mg
Inactive Ingredients
Ingredient NameStrength
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
Colorturquoise (capsule) , blue (dark blue band) Scoreno score
ShapeCAPSULESize15mm
FlavorImprint Code Orlistat;60
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71610-805-342280 in 1 BOTTLE; Type 0: Not a Combination Product03/22/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02188702/07/2007
Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)
Establishment
NameAddressID/FEIBusiness Operations
Aphena Pharma Solutions - Tennessee, LLC 128385585repack(71610-805)

Revised: 3/2024
Document Id: 14a73146-26ef-3d96-e063-6394a90ab4ce
Set id: 14a75092-f910-53df-e063-6294a90acc66
Version: 1
Effective Time: 20240327
 
Aphena Pharma Solutions - Tennessee, LLC