Cyclobenzaprine Hydrochloride
Product Images NDC 50436-0401

Product Visual Gallery

This gallery contains 5 technical images submitted to the FDA as part of the official labeling for Cyclobenzaprine Hydrochloride (NDC 50436-0401). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Unit Dose Services, 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

Image Description (50436 0401 1)

This is a medication for Cyclobenzaprine hydrochloride 10mg, containing 30 tablets, with NDC number 50436-0401-1. Each tablet contains Cyclobenzaprine hydrochloride, USP. It should be stored in a well-closed container at a controlled room temperature of 20-25°C (68-77 ° F). The package insert provides information about dosage. This medication was manufactured by CIPLA USA Inc in Warren, N) 07059, with MFG NDC number 69097-846-15, and MFG LOT number 3000000. The medication lot is X000 and the expiration date is X0000X. There are additional NDC related to Cyclobenzaprine hydrochloride 10mg. Blaseney and BRI A appear to be irrelevant names or misspelled words.*

FDA Label Image

Image Description (50436 0401 3)

This is a description of a medication with the NDC code 50436-0401-3. It is a bottle of Cyclobenzaprine Hydrochloride tablets containing 90 tablets, each of which has 10 mg of the active ingredient. The tablets are manufactured by Cipla USA, Inc. and are to be dispensed in a well-closed container. The label warns to keep the bottle out of reach of children and store it between 20-25°C (68-77°F). Directions for use are included in the package insert. The medication was packed by Unit Dose Services, LLC, located in Dania, L 33004. The lot number and expiration date are also provided.*

FDA Label Image

Image Description (7d5e3bad 7f85 4e2b 81c5 7981c456e45f 01)

FDA Label Image

Image (7d5e3bad 7f85 4e2b 81c5 7981c456e45f 02)

This text provides a summary of the side effects and their incidence rates observed during clinical trials of Cyclobenzaprine HCI tablets. The side effects mentioned are drowsiness, dry mouth, fatigue, and headache. The text shows the percentage of patients who experienced these side effects in two different dosage strengths (5mg and 10mg) compared to a placebo. The number of patients studied in each group is also provided.*

FDA Label Image

Image (7d5e3bad 7f85 4e2b 81c5 7981c456e45f 03)

Cyclobenzaprine HCl (a muscle relaxant) was tested in clinical studies and a surveillance program to study its effects on patients. In the clinical studies, patients experienced 39% drowsiness, 2% dry mouth, and 1% dizziness when taking Cyclobenzaprine HCl tablets at a dose of 10 mg. The results of a surveillance program showed that 16% of patients experienced drowsiness, 7% dry mouth, and 3% dizziness.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.