Acetylcysteine
Product Images NDC 0517-7630

Product Visual Gallery

This gallery contains 17 technical images submitted to the FDA as part of the official labeling for Acetylcysteine (NDC 0517-7630). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by American Regent, Inc., 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 Solution 1)

Chemical structure of acetylcysteine showing its molecular arrangement with key groups including a thiol (HS-), acetyl amide (NHCOCH3), carboxylic acid (COOH), and central carbon atom bonded to hydrogen.*

FDA Label Image

10 mL (20%) Carton (Acetylcysteine Solution 10)

Label for Acetylcysteine Solution USP 20% (200 mg/mL) by American Regent, Inc. The label indicates this mucolytic or oral administration solution comes in 3 x 10 mL vials, is preservative free, and not for injection. Usage instructions include storage in refrigerator after opening and discarding after 96 hours.*

FDA Label Image

30 mL (20%) Container (Acetylcysteine Solution 11)

Acetylcysteine Solution USP 20% (200 mg/mL) in a 30 mL vial. Label states it is for inhalation or oral administration, not for injection, and preservative free. The product is labeled Rx only and manufactured by American Regent, Inc., Shirley, NY. Additional information includes storage instructions and a warning to discard the container 96 hours after opening.*

FDA Label Image

30 mL (20%) Carton (Acetylcysteine Solution 12)

Label for Acetylcysteine Solution USP 20% (200 mg/mL) by American Regent, Inc. The label indicates it is for inhalation or oral administration, not for injection, preservative-free, and provided in 3 x 30 mL vials. Storage instructions specify refrigeration after opening and discarding after 96 hours. The label includes warnings, ingredients, and barcode information.*

FDA Label Image

Acetylcysteine Solution 13

A small white label containing a Data Matrix 2D barcode above several lines of black printed text. The text includes lot number (0000), expiration date (01/2099), GTIN code, and a serial number. No proprietary name or dosage details are visible on this label.*

FDA Label Image

Acetylcysteine Solution 14

Part of a packaging label for Acetylcysteine by American Regent, Inc., showing a 2D barcode and printed lot number, expiration date (01/2099), GTIN, and serial number. Specific strength and dosage form details are not visible in this image.*

FDA Label Image

Acetylcysteine Solution 15

A data matrix barcode and associated product tracking information including lot number, expiration date, Global Trade Item Number (GTIN), and serial number. The lot number is 0000, expiration date is January 1999, GTIN is 00305177510032, and serial number is 200003.*

FDA Label Image

Acetylcysteine Solution 16

Label section of Acetylcysteine product showing a 2D barcode, lot number (0000), expiration date (January 1999), GTIN (00305177610039), and serial number (1). No dosage strength or form visible.*

FDA Label Image

Acetylcysteine Solution 17

A small data matrix code next to printed alphanumeric data including a lot number (0000), expiration date (JAN 99), GTIN (00305177630037), and serial number (0). The information appears to be batch and product identification details, likely related to Acetylcysteine product packaging.*

FDA Label Image

Figure (Acetylcysteine Solution 2)

A semilogarithmic line chart showing plasma acetaminophen concentration (in µg/mL) over time post-ingestion (hours). Two reference lines indicate critical concentration thresholds at 4 hours (200 µg/mL) and 12 hours (50 µg/mL), used to assess risk of hepatotoxicity and guide continuation of acetylcysteine treatment.*

FDA Label Image

4 mL (10%) Container (Acetylcysteine Solution 3)

Label for Acetylcysteine Solution USP 10% (100 mg/mL) by American Regent, Inc. The 4 mL vial is Rx Only, for inhalation or oral administration, not for injection. The label includes composition details, storage instructions, and a warning to discard the vial 96 hours after opening.*

FDA Label Image

4 mL (10%) Carton (Acetylcysteine Solution 4)

Label for Acetylcysteine 10% solution (100 mg/mL) by American Regent, Inc. The product is supplied in 25 vials of 4 mL each. It is indicated for inhalation as a mucolytic agent or oral administration as an acetaminophen antidote, and is preservative-free. The label includes storage instructions, a warning to discard the container 96 hours after opening, and states the solution is not for injection.*

FDA Label Image

4 mL (20%) Container (Acetylcysteine Solution 5)

Acetylcysteine 20% (200 mg/mL) solution USP vial label by American Regent, Inc. The 4 mL vial is indicated for inhalation or oral administration. The label states 'Rx Only,' 'Preservative Free,' and clearly notes NOT FOR INJECTION. It includes storage instructions and a warning to discard the container 96 hours after opening.*

FDA Label Image

4 mL (20%) Carton (Acetylcysteine Solution 6)

Acetylcysteine 20% (200 mg/mL) solution label for 25 x 4 mL vials by American Regent, Inc. The label indicates use for inhalation or oral administration, is preservative free, and is not for injection. Storage instructions and warnings about pH and container use are also included, along with the NDC 0517-7604-25.*

FDA Label Image

10 mL (10%) Container (Acetylcysteine Solution 7)

Acetylcysteine 10% (100 mg/mL) solution label for inhalation or oral administration, presented in a 10 mL preservative-free vial. The label prominently states 'NOT FOR INJECTION' and includes storage instructions and warnings. Labeler is American Regent, Inc., Shirley, NY.*

FDA Label Image

10 mL (10%) Carton (Acetylcysteine Solution 8)

Label for Acetylcysteine Solution USP 10% (100 mg/mL) by American Regent, Inc. The label indicates the product as a solution for inhalation or oral administration, not for injection. It includes NDC 0517-7510-03, packaging of 3 x 10 mL vials, and storage instructions with a warning to discard the container after 96 hours.*

FDA Label Image

10 mL (20%) Container (Acetylcysteine Solution 9)

Acetylcysteine solution, USP 20% (200 mg/mL) in a 10 mL preservative-free vial. The label indicates use for inhalation or oral administration as an acetaminophen antidote and prominently states NOT FOR INJECTION. Manufactured by American Regent, Inc., Shirley, NY, the label includes storage instructions and a warning to discard the container 96 hours after opening.*

* 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.