General Information
Revision date
2024-06-26
Product name
Naproxen and Esomeprazole Magnesium Delayed-Release Tablets
Chemical name
Esomeprazole Magnesium 5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2- pyridyl)methyl]sulfinyl]benzimidazole, magnesium salt (2 1)
1.2.1 Relevant identified uses
Juvenile Idiopathic Arthritis (JIA) in adolescent patients Naproxen: (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid
Manufacturer Name
ScieGen Pharmaceuticals, Inc
Icons in SDS
Company Information
company name
ScieGen Pharmaceuticals, Inc
Section 2
SECTION 2: Hazards identification
Fire and Explosion Expected to be non-combustible
Environmental hazards
Not considered hazardous when handled under normal conditions. Naproxen and esomeprazole magnesium delayed-release tablets are contraindicated in the following patients: i) History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients. Health ii) Contraindicated in patients receiving rilpivirine-containing products. iii) Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to naproxen, esomeprazole magnesium, substituted benzimidazole, or to any components of the drug product, including omeprazole. Hypersensitivity reactions to esomeprazole may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria.