Label: ALLI- orlistat capsule

  • NDC Code(s): 0135-0461-01, 0135-0461-02, 0135-0461-03, 0135-0461-05, view more
    0135-0461-06, 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

Drug Label Information

Updated April 19, 2018

If you are a consumer or patient please visit this version.

  • Active ingredient (in each sealed capsule)

    Orlistat 60 mg

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  • Purpose

    Weight loss aid

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  • Use

    for weight loss in overweight adults, 18 years and older, when used along with a reduced-calorie and low-fat diet
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  • 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.

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  • 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.

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  • Other information

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

    FD&C Blue No. 2, edible ink, gelatin, iron oxide, microcrystalline cellulose, povidone, sodium lauryl sulfate, sodium starch glycolate, talc, titanium dioxide

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  • 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.

    Distributed by:

    GSK Consumer Healthcare

    Warren, NJ 07059 Made in India

     
    1-800-671-2554

    www.myalli.com

    ©2015 GSK group of companies or its licensor. All rights reserved.

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  • Principal Display Panel

    NDC 0135-0461-01

    alli®

    Orlistat 60mg Capsules

    Weight Loss Aid

    60 CAPSULES

    Starter Pack

    SEE TOP OF PACKAGE FOR LISTING OF CONTENTS

    FDA approved

    non-prescription

    weight loss aid

    Helps you lose more weight than dieting alone

    17-009CHFS

    17-009CHFS_alli_60 ct.JPG
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  • INGREDIENTS AND APPEARANCE
    ALLI 
    orlistat capsule
    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)
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