aripiprazole 15 MG Disintegrating Oral Tablet

1 INDICATIONS AND USAGE Aripiprazole orally disintegrating tablets are indicated for the treatment of: Schizophrenia [ see CLINICAL STUDIES ( 14.1 ) ] Additional pediatric use information is approved for Otsuka America Pharmaceutical, Inc.’s ABILIFY ® (aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. Aripiprazole is an atypical antipsychotic. The oral formulation is indicated for: Schizophrenia ( 14.1 )

Dr. Reddy's Laboratories Inc

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] off label use` `[3] fatigue` `[4] pain` `[5] seizure` `[6] toxicity to various agents` `[7] completed suicide` `[8] maternal exposure during pregnancy` `[9] alopecia` `[10] rash`

4 years ago

ROUND PINK SG 331

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied

ARIPIPRAZOLE ORALLY DISINTEGRATING tablets, USP are round tablets with markings on either side.

ARIPIPRAZOLE ORALLY DISINTEGRATING tablets, USP are available in the strengths and packages listed in Table 33. Table 33:

ARIPIPRAZOLE ORALLY DISINTEGRATING Tablets, USP Presentations Tablet Strength Tablet Color Tablet Markings Pack Size NDC Code 10 mg pink (with scattered specks) “SG 330” Bottle of 30 43598-733-30 15 mg pink (with scattered specks) “SG 331” Bottle of 30 43598-734-30 16.2 Storage Tablets Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

More pills like ROUND SG 331

Related Pills

aripiprazole 10 MG Disintegrating Oral Tablet

Dr. Reddy's Laboratories Inc

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

PillSync may earn a commission via links on our site