ALLI

Manufacturer: Aphena Pharma Solutions - Tennessee, LLC
Effective date: 2024-03-27
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 00:10:23

Label at a glance#

ProductALLI

Active ingredientORLISTAT

Label structure10 sections

Dosage and administration

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 mor...

Storage and handling

store at 20 - 25 o C (68 - 77 o F) protect drug from excessive light, humidity and temperatures over 30 o C (86 o F)

Contacts and useful links#

PhoneLabel contact1-800-671-2554

Websitewww.myalli.com

www.myalli.com

Label contents#

Full prescribing information#

Active ingredient (in each sealed capsule)

OTC - ACTIVE INGREDIENT SECTION

Orlistat 60 mg

Purpose

OTC - PURPOSE SECTION

Weight loss aid

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Organ transplant alert:

SPL UNCLASSIFIED SECTION

do not use if you have had an organ transplant. Orlistat interferes with the medicines used to prevent transplant rejection.

Allergy alert:

SPL UNCLASSIFIED SECTION

do not use if you are allergic to any of the ingredients in orlistat capsules

Do not use

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

gallbladder problems
kidney stones
pancreatitis

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

call toll-free 1-800-671-2554

Additional information

SPL UNCLASSIFIED SECTION

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.

Made in India

REPACKAGING INFORMATION

SPL UNCLASSIFIED SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

71610-805-34

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
723846	Alli 60 MG Oral Capsule	PSN	1
692876	orlistat 60 MG Oral Capsule	PSN	1
723846	orlistat 60 MG Oral Capsule [Alli]	SBD	1
692876	orlistat 60 MG Oral Capsule	SCD	1
723846	Alli 60 MG Oral Capsule	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
ORLISTAT Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
b3f93084-d1af-0d2d-125b-736522e0a7a2	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71610-805-34	ALLI	2280 in 1 BOTTLE	CAPSULE	2280		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-805	ALLI (ORLISTAT) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ]	1	Current NDC, 1 package rows	20240330_14a75092-f910-53df-e063-6294a90acc66.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-805-34	EA - Each	71610-805	2158d292-1ce1-49cc-8bf1-f5ef2f63f453	1	2024-05-16
0135-0461-01	EA - Each	0135-0461	060dcda2-78a0-40a4-9c3b-e21127b35e63	1	2021-05-05
0135-0461-02	EA - Each	0135-0461	b587d8e8-bdf7-455b-a8dd-f9538f9cf317	1	2012-07-24
0135-0461-05	EA - Each	0135-0461	61e49d90-2834-484b-b6cb-3acf721107ed	1	2012-07-24
0135-0461-06	EA - Each	0135-0461	62c7e670-db2d-4367-b445-42e246996c21	1	2012-07-24
0135-0461-07	EA - Each	0135-0461	59c364d2-2aa2-497a-8993-7ff5e80e723f	1	2024-04-05

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

ALLI
orlistat
FD&C BLUE NO. 2
GELATIN, UNSPECIFIED
FERROUS OXIDE
MICROCRYSTALLINE CELLULOSE
POVIDONE, UNSPECIFIED
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A
TALC
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
71610-805	71610-805-34
0135-0461

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
FD&C BLUE NO. 2	L06K8R7DQK	IACT
GELATIN, UNSPECIFIED	2G86QN327L	IACT
FERROUS OXIDE	G7036X8B5H	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
POVIDONE, UNSPECIFIED	FZ989GH94E	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
SODIUM STARCH GLYCOLATE TYPE A	H8AV0SQX4D	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
ORLISTAT	95M8R751W8	ACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021887-001	ALLI	ORLISTAT	60MG	CAPSULE / ORAL		RLD, RS	2007-02-07

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021887-001	ALLI	60MG	CAPSULE / ORAL	RLD, RS	2007-02-07	`3a93d1ddd44b…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ALLI	ORLISTAT	Haleon US Holdings LLC	a2d3bd73-f3af-4ea5-a57c-66b0004cfe4f	2026-03-18	Warnings	Exact identifier ndc (product): 0135-0461
ALLI	ORLISTAT	Aphena Pharma Solutions - Tennessee, LLC	14a75092-f910-53df-e063-6294a90acc66	2024-03-27	Warnings	Exact identifier ndc (package): 71610-805-34 ndc (product): 71610-805 ndc11 (package): 71610080534 spl id: 14a73146-26ef-3d96-e063-6394a90ab4ce spl set id: 14a75092-f910-53df-e063-6294a90acc66

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.