FLEQSUVY (Page 3 of 3)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

FLEQSUVY (baclofen oral suspension) contains 25 mg per 5 mL (5 mg/mL) baclofen. It is a concentrated orange to yellow-colored, grape-flavored suspension and is supplied in high-density polyethylene (HDPE) bottles with white, polypropylene, child-resistant closures with a foam liner and heat induction layered inner seal.

120 mL, NDC 52652-6001-1

300 mL, NDC 52652-6001-2

16.2 Storage and Handling

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15° and 30° (59° and 86° F) (see USP Controlled Room Temperature).

Discard unused portion 2 months after first opening.

17 PATIENT COUNSELING INFORMATION

Administration Instructions

Inform patients that FLEQSUVY is a concentrated formulation. Instruct patients or caregivers to use an oral dosing syringe and not to use a household teaspoon to correctly measure the prescribed amount of medication. Inform patients that oral dosing syringes may be obtained from their pharmacy. Instruct patients to shake before using [see Dosage and Administration (2.1, 2.3)].

Risks Related to Sudden Withdrawal of FLEQSUVY

Advise patients and caregivers not to discontinue use of FLEQSUVY without consulting with their healthcare provider because sudden withdrawal of FLEQSUVY can result in serious complications that include hallucinations, seizures, high fever, confusion, muscle stiffness, multiple organ-system failure, and death [see Warnings and Precautions (5.1)]. Inform patients that early symptoms of FLEQSUVY withdrawal may include increased spasticity, itching, and tingling of extremities.

Neonatal Withdrawal Symptoms

Advise patients to notify their healthcare provider if they are pregnant, plan to become pregnant, or plan to breastfeed [see Warnings and Precautions (5.2) and Use in Specific Populations (8.2)].

Increased Risk of Drowsiness with Alcohol and Other CNS Depressants

Advise patients that FLEQSUVY may cause drowsiness, and that they should avoid the operation of automobiles or other dangerous machinery, or activities made hazardous by decreased alertness when starting FLEQSUVY or increasing the dose until they know how the drug affects them [see Warnings and Precautions (5.3)]. Inform patients and their caregivers that the drowsiness associated with FLEQSUVY use can be worsened by alcohol and other CNS depressants. Advise patients to read all medicine labels carefully, and to tell their healthcare provider about all prescription and nonprescription drugs they may use.

Storage

Instruct patients to store FLEQSUVY at room temperature and to discard unused portion 2 months after first opening [see How Supplied/Storage and Handling (16.2)].

FLEQSUVY is a registered trademark of Azurity Pharmaceuticals, Inc.

Manufactured for:

Azurity Pharmaceuticals, Inc. Woburn, MA 01801

Patent: https://azurity.com/patents

This product’s labeling may have been updated. For current Full Prescribing Information, please visit www.FLEQSUVY.com

PN: 65628-00623

REV: 01 02/2023

PRINCIPAL DISPLAY PANEL — Bottle Label

Principal Display Panel -- Bottle Label
(click image for full-size original)

NDC 52652-6001-1 Rx Only

FLEQSUVY®
(baclofen oral suspension)

25 mg per 5 mL
(5 mg/mL)
Concentrated Formulation

ATTENTION: This is a concentrated baclofen
formulation of 25 mg/5 mL (5 mg/mL).

Manufactured for:
azurity®
pharmaceuticals
Woburn, MA 01801 USA

120 mL

KEEP THIS AND ALL
MEDICATIONS OUT OF THE
REACH OF CHILDREN

Each mL contains 5 mg of baclofen USP

Recommended Dosage:
See prescribing information.

Store at 20°C to 25°C (68°F to 77°F)
excursions permitted from 15°C to 30°C (59°F to 86°F)
[see USP Controlled Room Temperature].

Date of first opening _______ / _______ / _______ Discard unused portion 2 months after first opening.

SHAKE BEFORE USING

FLEQSUVY baclofen suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52652-6001
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACLOFEN (BACLOFEN) BACLOFEN 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
D&C YELLOW NO. 10
FD&C RED NO. 40
HYDROXYETHYL CELLULOSE, UNSPECIFIED
PROPYLENE GLYCOL
WATER
DIMETHICONE
SILICON DIOXIDE
SODIUM BENZOATE
SUCRALOSE
Product Characteristics
Color Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52652-6001-1 1 BOTTLE in 1 CARTON contains a BOTTLE
1 120 mL in 1 BOTTLE This package is contained within the CARTON (52652-6001-1)
2 NDC:52652-6001-2 1 BOTTLE in 1 CARTON contains a BOTTLE
2 300 mL in 1 BOTTLE This package is contained within the CARTON (52652-6001-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA215602 02/07/2022
Labeler — Azurity Pharmaceuticals, Inc. (117505635)

Revised: 02/2023 Azurity Pharmaceuticals, Inc.

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