Myalept
Product Images NDC 76431-210

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 82 technical images submitted to the FDA as part of the official labeling for Myalept (NDC 76431-210). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Amryt Pharmaceuticals Designated Activity Company, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

Product Images & Figures Index

FDA Label Image

Check For Expiration Date (Image 06)

Check For Expiration Date (Image 06)
Myalept (metreleptin) injectable solution vial with label showing dosage information, lot number, and expiration date fields. The clear glass vial has a silver cap and a white label with purple and black text. It is manufactured by Amryt Pharmaceuticals Designated Activity Company. Product NDC: 76431-210.*
FDA Label Image

Water For Injection (Image 07)

Water For Injection (Image 07)
Vial labeled 'Water for Injection' with a clear glass body and a purple cap, showing no proprietary or brand name. The vial is a small injectable container typically used as a diluent or sterile water for injection.*
FDA Label Image

Myalept Powder (Image 08)

Myalept Powder (Image 08)
Myalept injection vial from Amryt Pharmaceuticals Designated Activity Company. The clear glass vial contains a transparent liquid and features a silver cap with a gray rubber stopper. The vial label is white with no visible text or markings in the image provided.*
FDA Label Image

Alcohol Wipes (Image 09)

Alcohol Wipes (Image 09)
The image shows two small, rectangular sachets labeled 'Alcohol Wipe'. Each sachet contains a single alcohol wipe, typically used for disinfecting skin before an injection or procedure. No specific branding or manufacturer information is visible on the sachets.*
FDA Label Image

Wash Hands (Image 10)

Wash Hands (Image 10)
An instructional illustration showing a person washing hands under running water from a faucet. Soap is being dispensed from a pump bottle above the hands, emphasizing hand hygiene.*
FDA Label Image

Alcohol Swabs (Image 11)

Alcohol Swabs (Image 11)
An instructional illustration labeled '1b' showing two small sealed packets, each with 'STERILE POWDER' text visible, presumably representing packaging or preparation steps for a sterile powder product.*
FDA Label Image

Remove Vial Caps (Image 12)

Remove Vial Caps (Image 12)
An instructional diagram showing a vial labeled 'Water for Injection' and a hand removing the protective cap from a vial. This illustration is likely part of preparation or administration steps for an injectable medication, possibly associated with Myalept by Amryt Pharmaceuticals.*
FDA Label Image

Clean Bottles With Alcohol (Image 13)

Clean Bottles With Alcohol (Image 13)
An instructional illustration showing a hand preparing an injection vial labeled 'Water for Injection.' The hand is holding a needle cap above the vial, suggesting needle attachment or removal, with another sealed vial visible in the background.*
FDA Label Image

Mixing Syringe (Image 14)

Mixing Syringe (Image 14)
Myalept prefilled syringe, clear barrel with black measurement markings from 0.1 to 1.0 mL, purple-tinted needle shield, clear plunger, and gray thumb press. Labeled by Amryt Pharmaceuticals Designated Activity Company. No visible specific strength or additional text information.*
FDA Label Image

Water For Injection (Image 15)

Water For Injection (Image 15)
Myalept Water for Injection in a clear glass vial with a silver cap and white label. The label displays "Water for Injection" in black text. The vial appears to be the product container for injection use, labeled by Amryt Pharmaceuticals Designated Activity Company.*
FDA Label Image

Step 2a (Image 17)

Step 2a (Image 17)
Myalept carton packaging label showing the front panel. The product name Myalept is prominently displayed along with the labeler Amryt Pharmaceuticals Designated Activity Company. The label includes the NDC number 76431-210. The carton design uses blue and beige colors with white text highlighting the product branding.*
FDA Label Image

Pull Cover (Image 18)

Pull Cover (Image 18)
An instructional illustration showing a hand holding a syringe while another hand is removing the cap from the syringe tip. A red arrow indicates the direction of cap removal, suggesting preparation for injection.*
FDA Label Image

Pull Down Plunger (Image 19)

Pull Down Plunger (Image 19)
An instructional illustration labeled '2c' showing hands preparing a syringe with a needle attached to a vial or ampule. The illustration indicates pulling the syringe plunger downwards with a red arrow, suggesting drawing fluid into the syringe as part of an administration or preparation process.*
FDA Label Image

Line Up With Black Rim (Image 20)

Line Up With Black Rim (Image 20)
An instructional illustration showing a close-up view of a syringe filled to the 2.2 mL mark. The image highlights the volume measurement on the syringe with a pointer labeled '2.2 mL,' demonstrating proper dosage measurement technique.*
FDA Label Image

Set Vial On Surface (Image 21)

Set Vial On Surface (Image 21)
An instructional illustration showing a hand holding a syringe that is being inserted into the top of a vial labeled "Myalept." The image likely demonstrates how to draw medication from the vial using the syringe for dosing or administration.*
FDA Label Image

Push Needle (Image 22)

Push Needle (Image 22)
An instructional illustration showing a hand holding a syringe above a vial labeled "Myalept Injection". The syringe is being pressed downward with a red arrow indicating the direction, suggesting the process of drawing or injecting medication from or into the vial.*
FDA Label Image

Turn Vial (Image 23)

Turn Vial (Image 23)
An instructional illustration showing a hand holding a Myalept vial upside down while drawing medication into a syringe. The image includes the step label '2e' in a green circle, indicating a step in the preparation or administration process.*
FDA Label Image

Pull Plunger (Image 24)

Pull Plunger (Image 24)
An instructional diagram showing how to use a syringe with a vial. The illustration highlights drawing liquid from the vial into the syringe, with a zoomed-in view of the syringe measurement markings to guide accurate dosing.*
FDA Label Image

Check For Air Pockets (Image 25)

Check For Air Pockets (Image 25)
An illustration showing a syringe being held by a hand. The syringe barrel is labeled with volume marks, and a small air pocket is indicated inside the syringe just above the 1 mL mark. The image highlights the presence of an air pocket within the syringe before injection.*
FDA Label Image

Push Plunger (Image 26)

Push Plunger (Image 26)
An instructional diagram showing a hand holding a syringe and vial. The syringe is being filled from the vial, with a red arrow pointing upward, suggesting the drawing or pulling up of liquid into the syringe. The image appears to illustrate a step in medication preparation or administration.*
FDA Label Image

Check For Airbubbles (Image 27)

Check For Airbubbles (Image 27)
An instructional illustration showing a syringe with a marked plunger, highlighting an air bubble near the 2 ml mark. The image indicates a '2h' label and points out the air bubble with red text, likely as a caution or part of dosing instructions.*
FDA Label Image

Push Plunger (Image 28)

Push Plunger (Image 28)
Illustration showing a person holding a syringe with one hand and pressing the plunger with the other hand, indicated by a red arrow pointing upward. The image likely demonstrates a step in preparing or drawing medication into the syringe.*
FDA Label Image

Pull Plunger (Image 29)

Pull Plunger (Image 29)
An instructional diagram showing a hand holding a Myalept medication bottle inverted above a syringe. A zoomed-in circle highlights the liquid level inside the bottle, focusing on measurement markings to guide accurate dosing.*
FDA Label Image

Remove From Vial (Image 30)

Remove From Vial (Image 30)
Instructional illustration showing a hand holding a vial labeled Myalept, with liquid being drawn into a syringe. The image demonstrates the step of filling the syringe from the vial, with a focus on proper handling technique for medication preparation.*
FDA Label Image

Filled Syringe (Image 31)

Filled Syringe (Image 31)
The image shows a syringe with measurement markings. The syringe appears to be a standard medical device used for injections, featuring a plunger, a graduated barrel with volume indicators, and a needle attached at the tip. The syringe is transparent with black measurement markings.*
FDA Label Image

Powder Vial (Image 32)

Powder Vial (Image 32)
Myalept single-dose vial with clear solution, shown without external packaging or label details. The vial is glass with a gray rubber stopper and aluminum seal. No text or other identifying marks are visible on the vial itself. Manufacturer is Amryt Pharmaceuticals Designated Activity Company as verified.*
FDA Label Image

Set The Vial (Image 34)

Set The Vial (Image 34)
An instructional illustration showing a syringe drawing liquid from a vial, indicating proper technique for medication preparation. A hand holds the vial while the other hand pulls the syringe plunger up to extract the liquid, with a red arrow highlighting the motion direction.*
FDA Label Image

Tilt The Vial (Image 35)

Tilt The Vial (Image 35)
An instructional illustration depicting two hands preparing an injectable dose. One hand holds a vial with its stopper removed, while the other hand inserts a syringe needle into the vial, drawing up liquid medication. This image likely accompanies administration instructions for Myalept by Amryt Pharmaceuticals.*
FDA Label Image

Push Plunger (Image 36)

Push Plunger (Image 36)
An instructional illustration showing a hand holding a syringe with the plunger being pushed down to possibly mix or draw liquid from a vial held by another hand below. The image demonstrates part of a medication preparation process for Myalept.*
FDA Label Image

Add The Liquid (Image 37)

Add The Liquid (Image 37)
An illustrated diagram of a vial with a rubber stopper being accessed by a syringe needle, showing the process of drawing liquid medication from the vial. The vial contains a clear liquid and is depicted from a slightly angled side view.*
FDA Label Image

Remove The Needle (Image 38)

Remove The Needle (Image 38)
An instructional illustration showing steps for preparing an injection. The left side depicts drawing liquid into a syringe from a vial, and the right side shows inserting the syringe into a vial's rubber stopper. This visual guide relates to preparing the Myalept injection.*
FDA Label Image

Mix Powder And Liquid (Image 39)

Mix Powder And Liquid (Image 39)
An instructional illustration depicting a hand holding a Myalept vial. The hand is shown twisting the vial cap to indicate how to open it, with arrows emphasizing the turning motion.*
FDA Label Image

Mixed Vial (Image 40)

Mixed Vial (Image 40)
An illustration of a small clear glass vial containing a liquid with a gray rubber stopper and a gray cap. The vial is shown with a shadow below, indicating it is standing upright. No text or labels are visible on the vial itself, and it is displayed against a white background with a slight horizontal line suggesting a surface.*
FDA Label Image

Mixed Vial (Image 41)

Mixed Vial (Image 41)
Myalept carton packaging label by Amryt Pharmaceuticals Designated Activity Company. The label shows the proprietary name Myalept prominently with blue and purple text on a white background. The packaging is a rectangular box with product information and a logo visible on the front face.*
FDA Label Image

Alcohol Wipes (Image 42)

Alcohol Wipes (Image 42)
Myalept alcohol wipe packaging showing two sealed individual packets. Each packet is white with a blue border and labeled with red text "Alcohol Wipe." The image indicates packaging for antiseptic alcohol wipes supplied by Amryt Pharmaceuticals Designated Activity Company.*
FDA Label Image

Take Mixed Vial (Image 43)

Take Mixed Vial (Image 43)
An illustration of a glass vial with a rubber stopper and metal cap, labeled for single use only. The vial is depicted on a white background with a gold outline and a gold circular icon labeled '3e' in the top left corner.*
FDA Label Image

Set Vial On Surface (Image 44)

Set Vial On Surface (Image 44)
An instructional diagram showing a vial labeled Myalept, indicating a wait time of 10-15 minutes. The image suggests a process involving the Myalept vial with a step numbered 3f, likely part of a larger sequence.*
FDA Label Image

Wash Hands (Image 45)

Wash Hands (Image 45)
An instructional illustration showing washing hands under running water from a faucet. The image includes soap being applied to the hands, emphasizing hygiene. A label indicates a 3-minute duration for the process.*
FDA Label Image

Remove Wipes (Image 46)

Remove Wipes (Image 46)
An instructional illustration showing two strips labeled 'Myalept' designed for administration every 3 hours, indicating timing guidance for use.*
FDA Label Image

Clean Vial Top (Image 47)

Clean Vial Top (Image 47)
An instructional illustration showing a person holding a vial labeled Myalept and preparing to remove the cap, indicating a step in medication preparation or administration.*
FDA Label Image

Check Mixed Medicine (Image 48)

Check Mixed Medicine (Image 48)
The image shows a small vial of Myalept, a pharmaceutical product by Amryt Pharmaceuticals Designated Activity Company. The vial is clear with a gray stopper and a label featuring the brand name Myalept. The image is marked with a small circular icon labeled '3J' in the top left corner.*
FDA Label Image

Step 4a (Image 53)

Step 4a (Image 53)
Myalept is presented in a brown glass vial with a green, silver, and white label. The front label displays the proprietary name Myalept and includes the labeler Amryt Pharmaceuticals Designated Activity Company. This packaging is designed for a pharmaceutical product with NDC 76431-210.*
FDA Label Image

Medicine Vials (Image 80)

Medicine Vials (Image 80)
Myalept medication vial image showing a clear vial with a gray cap and a label that partially reads 'Myalept' and 'recombinant'. The label also contains purple and white design elements. The vial appears to be a liquid formulation for injection.*
FDA Label Image

Check Forair Bubbles (Image 81)

Check Forair Bubbles (Image 81)
An instructional illustration showing a comparison between a device with large air bubbles and the same device without large air bubbles, indicating the correct usage involves eliminating large air bubbles. The image juxtaposes two views of the device, one marked with an X for large air bubbles and the other marked with a check for small air bubbles.*
FDA Label Image

Principal Display Panel (11.3 mg Vial Label)

Principal Display Panel (11.3 mg Vial Label)
Label for Myalept (metreleptin) 11.3 mg per vial for injection by Amryt Pharmaceuticals DAC. The label specifies subcutaneous use only and storage between 36°F to 46°F (2°C to 8°C). It includes instructions for single-dose vial reconstitution with Water for Injection and multi-dose vial reconstitution with Water for Injection plus Bacteriostatic Water for Injection.*
FDA Label Image

Principal Display Panel (11.3 mg Vial Carton)

Principal Display Panel (11.3 mg Vial Carton)
Myalept (metreleptin) For Injection 11.3 mg per vial packaging label by Amryt Pharmaceuticals Designated Activity Company. The label includes active ingredient content, storage instructions, reconstitution details, usage directions, and manufacturer information. The label depicts barcodes and cautions such as prescription use only and keeping out of reach of children.*
FDA Label Image

Figure A (Metreleptin 01)

Figure A (Metreleptin 01)
Illustration showing components for preparation of Myalept injection. It features a vial labeled 'Water for Injection' with a cap, and a syringe labeled for mixing medicine. The syringe includes a plunger, longer needle, and needle cover, all clearly identified.*
FDA Label Image

Figure A (Metreleptin 02)

Figure A (Metreleptin 02)
Illustration showing components for using Myalept injection medicine, including a vial with powder and cap, two types of syringes for injection (insulin syringe marked in units and tuberculin syringe marked in mL), alcohol wipes, a sharps disposal container, stickers to note the discard date of the mixed medicine, and a pen for writing on the stickers.*
FDA Label Image

Figure B (Metreleptin 03)

Figure B (Metreleptin 03)
An instructional diagram showing a syringe with measurement lines indicating volume. The image highlights how to measure 2.2 mL by aligning the top rim of the plunger with the 2.2 mL line, emphasizing that the measurement is taken at the plunger's rim, not the dome top.*
FDA Label Image

Figure C (Metreleptin 04)

Figure C (Metreleptin 04)
An instructional diagram titled "How to measure your dose" showing three syringes: a 1 mL tuberculin syringe and two insulin syringes (1 mL and 0.3 mL). It explains dosing measurements and markings, indicating the plunger position for a 0.05 mL dose on two medication vials, and notes measurement increments for accuracy.*
FDA Label Image

Image (Metreleptin 05)

Image (Metreleptin 05)
Partial text panel showing dosing instructions with headings for dose amount in milliliters per day and a date entry field. The visible text includes 'Dose you will take each day' and 'Date.' The content appears to be part of directions for use.*
FDA Label Image

Image (Metreleptin 16)

Image (Metreleptin 16)
Myalept oral solution bottle with a red liquid inside, sealed with a white safety cap. The bottle is clear with a white label featuring the product name 'Myalept.' The label indicates the product is supplied by Amryt Pharmaceuticals Designated Activity Company.*
FDA Label Image

Sharps Disposal Container (Metreleptin 33)

Sharps Disposal Container (Metreleptin 33)
Myalept prescription drug vial with a red-orange body and a gray cap. The vial is a small glass container typically used for injectable solutions. The label or detailed text is not visible in the image. The product is by Amryt Pharmaceuticals Designated Activity Company.*
FDA Label Image

Figure (Metreleptin 50)

Figure (Metreleptin 50)
Illustration showing three types of syringes: a 1 mL tuberculin syringe, a 1 mL insulin syringe, and a 0.3 mL insulin syringe. Each syringe is labeled with its volume capacity and measurement markings along the barrel.*
FDA Label Image

Figure (Metreleptin 51)

Figure (Metreleptin 51)
Packaging image of Myalept, a clear liquid injectable drug vial with a gray rubber stopper and an aluminum seal. The vial is a small glass container commonly used for injectable pharmaceuticals. The label text is not fully legible in the image. Myalept is distributed by Amryt Pharmaceuticals Designated Activity Company.*
FDA Label Image

Figure (Metreleptin 52)

Figure (Metreleptin 52)
Myalept in a bottle form. The bottle has a white child-resistant cap with an inner safety seal. The bottle is a solid reddish-brown color and has no visible text or labeling on the bottle surface shown. The labeler is Amryt Pharmaceuticals Designated Activity Company, product NDC 76431-210.*
FDA Label Image

Figure (Metreleptin 54)

Figure (Metreleptin 54)
Instructional illustration showing hands holding a syringe and an injection pen or cartridge, with one hand holding the syringe and the other holding the cartridge. The image appears to demonstrate how to attach or prepare the injection device, related to Myalept use.*
FDA Label Image

Figure (Metreleptin 55)

Figure (Metreleptin 55)
An instructional illustration showing two hands: one holding a syringe and the other holding a vial with a cap. A red arrow between them indicates the step of inserting the syringe needle into the vial for medication preparation.*
FDA Label Image

Figure (Metreleptin 56)

Figure (Metreleptin 56)
Instructional illustration showing a hand pushing the plunger of a syringe downward, with an arrow indicating the direction of movement. The image is labeled with '4c,' suggesting a step in a procedure, possibly related to Myalept injection preparation or administration.*
FDA Label Image

Figure (Metreleptin 57)

Figure (Metreleptin 57)
Instructional illustration showing a hand holding a syringe being inserted into a vial, with another hand stabilizing the vial on a surface. The label includes a step marker "4d" indicating this is part of a multi-step process, likely related to preparing or administering the Myalept medication.*
FDA Label Image

Figure (Metreleptin 58)

Figure (Metreleptin 58)
An instructional illustration showing a hand holding a syringe being inserted into a vial. An arrow indicates the downward motion to draw liquid into the syringe from the vial.*
FDA Label Image

Figure (Metreleptin 59)

Figure (Metreleptin 59)
Illustration showing a hand holding a syringe being filled from a vial, demonstrating proper technique for drawing medication. The image is part of an instructional guide for using Myalept by Amryt Pharmaceuticals.*
FDA Label Image

Figure (Metreleptin 60)

Figure (Metreleptin 60)
An instructional illustration showing a hand holding a vial and a syringe, with an arrow indicating the downward direction of pushing the plunger to draw liquid into the syringe. This step is part of medication preparation or administration instructions for Myalept.*
FDA Label Image

Figure (Metreleptin 61)

Figure (Metreleptin 61)
An instructional illustration showing a syringe partially inserted into skin, highlighting a 4g air pocket inside the syringe barrel, labeled "Air pocket." The image emphasizes proper injection technique or air pocket awareness.*
FDA Label Image

Figure (Metreleptin 62)

Figure (Metreleptin 62)
An instructional illustration showing a hand holding a syringe with the thumb and forefinger stabilizing the syringe barrel. The other hand is pressing a plunger upward, indicated by a red arrow pointing up, suggesting the action of drawing liquid into or pushing liquid out of the syringe.*
FDA Label Image

Figure (Metreleptin 63)

Figure (Metreleptin 63)
Illustration showing a close-up view inside a syringe or similar device with an air bubble indicated and labeled. Measurement markings are visible alongside the liquid and the air bubble inside the chamber. The diagram emphasizes the air bubble's position and presence within the fluid column.*
FDA Label Image

Figure (Metreleptin 64)

Figure (Metreleptin 64)
An instructional illustration showing a hand holding a syringe connected to a vial. The plunger of the syringe is being pulled upward as indicated by a red arrow, demonstrating the step of drawing liquid from the vial into the syringe.*
FDA Label Image

Figure (Metreleptin 65)

Figure (Metreleptin 65)
An instructional illustration showing a hand holding a vial and drawing liquid into a syringe with a downward red arrow indicating the direction of drawing. The image is part of a step-by-step guide, labeled with '4i' in an orange circle.*
FDA Label Image

Figure (Metreleptin 66)

Figure (Metreleptin 66)
An instructional illustration showing two hands preparing a syringe by drawing liquid from a vial labeled with '4j' in an orange circle. The vial is held upside down above the syringe, with the needle inserted into the vial's rubber stopper, indicating the step of filling the syringe from the vial.*
FDA Label Image

Figure (Metreleptin 67)

Figure (Metreleptin 67)
Myalept injection syringe with orange safety needle cover. The syringe is marked with measurement markings and has a transparent barrel showing the plunger inside. The labeler is Amryt Pharmaceuticals Designated Activity Company.*
FDA Label Image

Figure (Metreleptin 68)

Figure (Metreleptin 68)
Myalept packaging label by Amryt Pharmaceuticals Designated Activity Company. The image shows a partially open blister pack with several white, round tablets visible inside. No dosage strength or count is visible on the blister or packaging shown.*
FDA Label Image

Figure (Metreleptin 69)

Figure (Metreleptin 69)
An illustration showing a red, cylindrical medical device with a white base and white top featuring a circular opening. The device has a hinge suggesting it may open or tilt. This image does not provide text or detailed labeling.*
FDA Label Image

Figure (Metreleptin 70)

Figure (Metreleptin 70)
An instructional illustration showing recommended injection areas for Myalept. The front view highlights the stomach and upper thigh, while the back view shows the back of the upper arm and the upper thigh as injection sites. The image is labeled 'Areas on body for Injection' and numbered 5a.*
FDA Label Image

Figure (Metreleptin 71)

Figure (Metreleptin 71)
Illustration showing a person pressing a small patch onto their skin with their finger. This is likely part of application instructions for the Myalept product by Amryt Pharmaceuticals.*
FDA Label Image

Figure (Metreleptin 72)

Figure (Metreleptin 72)
An instructional illustration showing a hand holding a syringe, injecting into the skin of a person's arm. The image highlights proper injection technique, likely related to subcutaneous administration.*
FDA Label Image

Figure (Metreleptin 73)

Figure (Metreleptin 73)
An instructional illustration showing a hand administering an injection with a syringe into a person's skin. The image highlights the insertion angle and technique using an arrow for visual guidance.*
FDA Label Image

Figure (Metreleptin 74)

Figure (Metreleptin 74)
Illustration showing a hand holding a syringe, positioned above the opening of a red bottle with a white cap, indicating injection or drawing liquid from the bottle. A small circular icon with '5d' is present on the left side.*
FDA Label Image

Figure (Metreleptin 75)

Figure (Metreleptin 75)
An instructional illustration showing a vial labeled "5e" with a note below it stating to store only if mixed with bacteriostatic water for injection. The image emphasizes storage instructions related to dilution of the product.*
FDA Label Image

Figure (Metreleptin 76)

Figure (Metreleptin 76)
A calendar illustration showing the month of January with the 2nd and 3rd days circled in red. The calendar displays dates from Sunday the 1st through Tuesday the 31st.*
FDA Label Image

Figure (Metreleptin 77)

Figure (Metreleptin 77)
The image is a portion of a packaging label for Myalept. It includes a boxed area where "Discard vial after dose on:" is printed, with a handwritten date noted as "January 5." The label appears designed for patient dosing instructions or vial discard information.*
FDA Label Image

Figure (Metreleptin 78)

Figure (Metreleptin 78)
An illustration showing a close-up of hands holding a small glass vial labeled Myalept, demonstrating the process of preparation or administration. The image focuses on the vial and the interaction with the fingers, without additional text or packaging details visible.*
FDA Label Image

Figure (Metreleptin 79)

Figure (Metreleptin 79)
Labels for Myalept vials by Amryt Pharmaceuticals, each stating "Discard vial after dose on:" followed by a blank line for date notation. The image shows multiple identical label stickers arranged in rows, intended for use in tracking vial discard dates after dosing.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.