Alli

Orlistat


Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Human Otc Drug
NDC 0135-0461
Alli also known as Orlistat is a human otc drug labeled by 'Glaxosmithkline Consumer Healthcare Holdings (us) Llc'. National Drug Code (NDC) number for Alli is 0135-0461. This drug is available in dosage form of Capsule. The names of the active, medicinal ingredients in Alli drug includes Orlistat - 60 mg/1 . The currest status of Alli drug is Active.

Drug Information:

Drug NDC: 0135-0461
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Alli
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Orlistat
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Capsule
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:ORLISTAT - 60 mg/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: NDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date: 07 Feb, 2007
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 07 May, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number: NDA021887
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:692876
723846
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
NUI:N0000175591
N0000009916
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:95M8R751W8
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class MOA:Lipase Inhibitors [MoA]
Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`.
Pharmacologic Class EPC:Intestinal Lipase Inhibitor [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class:Intestinal Lipase Inhibitor [EPC]
Lipase Inhibitors [MoA]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
0135-0461-0160 CAPSULE in 1 BOTTLE (0135-0461-01)01 Sep, 2016N/ANo
0135-0461-0290 CAPSULE in 1 BOTTLE (0135-0461-02)07 Feb, 2007N/ANo
0135-0461-03120 CAPSULE in 1 BOTTLE (0135-0461-03)07 Feb, 2007N/ANo
0135-0461-05120 CAPSULE in 1 BOTTLE (0135-0461-05)07 Feb, 2007N/ANo
0135-0461-06170 CAPSULE in 1 BOTTLE (0135-0461-06)07 Feb, 2007N/ANo
0135-0461-0721 CAPSULE in 1 BOTTLE (0135-0461-07)07 Feb, 2007N/ANo
0135-0461-082 BOTTLE in 1 CARTON (0135-0461-08) / 60 CAPSULE in 1 BOTTLE07 Feb, 2007N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Purpose:

Purpose weight loss aid

Product Elements:

Alli orlistat orlistat orlistat fd&c blue no. 2 gelatin, unspecified ferrous oxide microcrystalline cellulose povidone, unspecified sodium lauryl sulfate sodium starch glycolate type a potato talc titanium dioxide capsule dark blue band orlistat;60

Indications and Usage:

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

Warnings:

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: o gas with oily spotting o loose stools o 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.

Do Not 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: o gas with oily spotting o loose stools o 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.

When Using:

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: o gas with oily spotting o loose stools o 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.

Dosage and Administration:

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: o take 1 capsule with each meal containing fat o 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.

Stop Use:

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

Package Label Principal Display Panel:

Principal display panel ndc 0135-0461-01 alli orlistat 60 mg 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 1001165 front carton alli 60 count capsule carton

Further Questions:

Questions or comments? call toll-free 1-800-671-2554 additional information 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.my alli .com. 1-800-671-2554 distributed by: gsk consumer healthcare warren, nj 07059 trademarks are owned by or licensed to the gsk group of companies. ©2021 gsk group of companies or its licensor. made in india


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* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.