Acetylcysteine Solution
Product Images NDC 63323-692

15 FDA label images from Fresenius Kabi Usa, Llc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Acetylcysteine (NDC 63323-692). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Fresenius Kabi Usa, Llc, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Structural Formula Acetylcysteine (Ace0x 0001 01)

Structural Formula Acetylcysteine (Ace0x 0001 01)
Chemical structure diagram of acetylcysteine, showing its molecular arrangement including the acetyl group, thiol group, carboxylic acid group, and central carbon atom with attached hydrogen.*
FDA Label Image

Chart Plasma Or Serum Acetaminophen Concentration V Time Post-acetaminophen Ingestion (Ace0x 0001 02)

Chart Plasma Or Serum Acetaminophen Concentration V Time Post-acetaminophen Ingestion (Ace0x 0001 02)
A line graph showing plasma or serum acetaminophen concentration (mcg/mL) over time in hours post-acetaminophen ingestion. It features a solid line indicating the threshold above which hepatotoxicity is likely, and a broken line below indicating when to continue acetylcysteine treatment if assay values fall on or above it. The graph includes labeled reference points such as (200, 4 h) and (50, 12 h).*
FDA Label Image

Fk Logo (Ace0x 0001 03)

FDA Label Image

Principal Display Panel – 4 mL (10%) Tray Label (Ace0x 0001 04)

Principal Display Panel – 4 mL (10%) Tray Label (Ace0x 0001 04)
Acetylcysteine 10% (100 mg/mL) oral and inhalation solution in a 25 x 4 mL vial carton. The label indicates it is preservative-free, not for injection, and includes storage instructions, manufacturer Fresenius Kabi USA, LLC, and manufacturing origin India. The label has warnings and usage details relevant to mucolytic and acetaminophen antidote applications.*
FDA Label Image

Principal Display Panel – 4 mL (10%) Vial Label (Ace0x 0001 05)

Principal Display Panel – 4 mL (10%) Vial Label (Ace0x 0001 05)
Label for Acetylcysteine 10% solution, USP (100 mg/mL) oral and respiratory inhalation solution in a 4 mL vial. The label states it is preservative-free, not for injection, and for prescription use only. It includes storage instructions and manufacturer information for Fresenius Kabi USA, LLC.*
FDA Label Image

Principal Display Panel – 10 mL (10%) Tray Label (Ace0x 0001 06)

Principal Display Panel – 10 mL (10%) Tray Label (Ace0x 0001 06)
Label for Acetylcysteine 10% solution, USP, 100 mg/mL strength, in 3 x 10 mL vials. Intended for inhalation or oral administration as a mucolytic agent or acetaminophen antidote. Contains usage warnings, storage instructions, and manufacturer information for Fresenius Kabi USA, LLC. Includes barcode and instructions to discard opened containers after 96 hours.*
FDA Label Image

Principal Display Panel – 10 mL (10%) Vial Label (Ace0x 0001 07)

Principal Display Panel – 10 mL (10%) Vial Label (Ace0x 0001 07)
Label for Acetylcysteine 10% (100 mg/mL) solution in a 10 mL vial, labeled for inhalation or oral administration. Contains usage instructions, warnings including 'NOT FOR INJECTION' and preservative-free status. Manufactured by Fresenius Kabi USA, LLC, with storage instructions and a barcode present.*
FDA Label Image

Principal Display Panel – 30 mL (10%) Tray Label (Ace0x 0001 08)

Principal Display Panel – 30 mL (10%) Tray Label (Ace0x 0001 08)
Label for Acetylcysteine 10% (100 mg/mL) solution, USP, in a package of 3 x 30 mL vials. It is indicated for inhalation (mucolytic agent) or oral administration (acetaminophen antidote). The label states it is preservative-free, not for injection, and includes storage instructions and warnings. Manufactured for Fresenius Kabi USA, LLC, with the product made in India.*
FDA Label Image

Principal Display Panel – 30 mL (10%) Vial Label (Ace0x 0001 09)

Principal Display Panel – 30 mL (10%) Vial Label (Ace0x 0001 09)
Label for Acetylcysteine Solution USP 10% (100 mg/mL) in a 30 mL vial, indicated for oral and inhalation use. The label states it is not for injection, preservative free, and includes storage instructions. Manufactured for Fresenius Kabi USA, LLC, made in India, with space for lot, expiration, and opened date/time information.*
FDA Label Image

Principal Display Panel – 4 mL (20%) Tray Label (Ace0x 0001 10)

Principal Display Panel – 4 mL (20%) Tray Label (Ace0x 0001 10)
Acetylcysteine 20% (200 mg/mL) solution for inhalation or oral administration, presented in a package of 25 x 4 mL vials. The label states it is preservative free and not for injection. Manufactured by Fresenius Kabi USA, LLC, the product is stored at controlled room temperature with refrigeration recommended after opening. Made in India.*
FDA Label Image

Principal Display Panel – 4 mL (20%) Vial Label (Ace0x 0001 11)

Principal Display Panel – 4 mL (20%) Vial Label (Ace0x 0001 11)
Label for Acetylcysteine 20% (200 mg/mL) oral and inhalation solution, preservative-free. The 4 mL vial label includes usage instructions for mucolytic or acetaminophen antidote purposes, warnings against injection, storage guidelines, and batch detail placeholders. It is manufactured for Fresenius Kabi USA, LLC.*
FDA Label Image

Principal Display Panel – 10 mL (20%) Tray Label (Ace0x 0001 12)

Principal Display Panel – 10 mL (20%) Tray Label (Ace0x 0001 12)
Label for Acetylcysteine solution, USP 20% (200 mg/mL) in 3 x 10 mL vials by Fresenius Kabi USA, LLC. Intended for inhalation or oral administration. Label includes storage instructions, warnings, and manufacturer information, emphasizing 'Not for Injection' and preservative-free status.*
FDA Label Image

Principal Display Panel – 10 mL (20%) Vial Label (Ace0x 0001 13)

Principal Display Panel – 10 mL (20%) Vial Label (Ace0x 0001 13)
Label for Acetylcysteine Solution, USP 20% (200 mg/mL), a mucolytic agent/oral acetaminophen antidote, contained in a 10 mL vial. The label states it is preservative free, for inhalation or oral administration, not for injection, and prescription use only. Manufactured by Fresenius Kabi USA, LLC, made in India. Instructions include storage between 2°C and 8°C after opening and discard opened containers after 96 hours.*
FDA Label Image

Principal Display Panel – 30 mL (20%) Tray Label (Ace0x 0001 14)

Principal Display Panel – 30 mL (20%) Tray Label (Ace0x 0001 14)
Label for Acetylcysteine 20% (200 mg/mL) oral and inhalation solution, supplied in 3 x 30 mL vials by Fresenius Kabi USA, LLC. The label highlights it is preservative free, not for injection, and includes storage instructions with a warning to discard opened containers after 96 hours. It also lists ingredients and dosage instructions with batch details and a barcode.*
FDA Label Image

Principal Display Panel – 30 mL (20%) Vial Label (Ace0x 0001 15)

Principal Display Panel – 30 mL (20%) Vial Label (Ace0x 0001 15)
Acetylcysteine 20% (200 mg/mL) solution label for oral or inhalation use, preservative free, in a 30 mL vial. The label notes it is not for injection and includes storage instructions. Manufactured for Fresenius Kabi USA, LLC, the label also features warnings and usage directions, along with barcode and lot/expiration fields.*

* 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.