TEVA 5504 Pill — ORANGE CAPSULE, 16mm — Fluoxetine
| Imprint | TEVA / 5504 |
|---|---|
| Colour | ORANGE |
| Shape | CAPSULE |
| Size | 16 |
| Strength | OLANZAPINE 6 mg;FLUOXETINE HYDROCHLORIDE 25 mg |
| Dosage form | Capsule |
| Manufacturer | Teva Pharmaceuticals USA, Inc. |
| NDC | 0093-5504 |
| Schedule | — |
| Availability | Prescription only |
| Ingredients | OLANZAPINE[OLANZAPINE];FLUOXETINE HYDROCHLORIDE[FLUOXETINE] |
What does this imprint mean?
The imprint "TEVA 5504" is a code stamped or printed on the tablet or capsule by the manufacturer, used to identify the drug, its strength and the maker.
Active ingredient
Fluoxetine
Uses and warnings
BOXED WARNING: BOXED WARNING - Suicidal Thoughts and Behaviors: "Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies." Monitoring is required for all ages starting antidepressant therapy. "Fluoxetine is not approved for use in children less than 7 years of age." Key Warnings Include: - Serotonin syndrome risk when combined with other serotonergic drugs - Allergic reactions and rash (discontinue if occurs) - Activation of mania/hypomania in bipolar patients - Seizure risk in predisposed individuals - Weight loss and appetite changes - Abnormal bleeding (especially with NSAIDs/warfarin) - Angle-closure glaucoma in susceptible patients - Hyponatremia/SIADH - QT interval prolongation - Cognitive and motor impairment potential --- | BOXED WARNING - Suicidal Thoughts and Behaviors: "Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies." Monitoring is required for all ages starting antidepressant therapy. "Fluoxetine is not approved for use in children less than 7 years of age." Key Warnings Include: - Serotonin syndrome risk when combined with other serotonergic drugs - Allergic reactions and rash (discontinue if occurs) - Activation of mania/hypomania in bipolar patients - Seizure risk in predisposed individuals - Weight loss and appetite changes - Abnormal bleeding (especially with NSAIDs/warfarin) - Angle-closure glauc
Fluoxetine is indicated for: - "Acute and maintenance treatment of Major Depressive Disorder" - "Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD)" - "Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa" - "Acute treatment of Panic Disorder, with or without agoraphobia" ---
How to identify this pill
- • Check the imprint matches exactly: "TEVA 5504".
- • Confirm the colour (ORANGE) and shape (CAPSULE).
- • Compare the size (16) against a ruler if possible.
- • When in doubt, confirm with a pharmacist before taking any medication.
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Official references
Source: FDA Structured Product Label via NLM Pillbox archive (retired 2021); source file d5f35371-be0b-4d03-b833-d3d826781dd2.xml