Patient information: uses, side effects, how to take - Galantamine
Storage
Galantamine Oral Solution, USP should be stored at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] DO NOT FREEZE.
Keep out of reach of children.
Galantamine Oral Solution USP, 4 mg/mL
Each 1 mL contains the equivalent of 4 mg galantamine in an aqueous solution.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Distributed by:
Hikma Pharmaceuticals USA Inc.
Berkeley Heights, NJ 07922
C50000575/03
Revised October 2023
About this document
Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 078185
· View the label on DailyMed
Revision date stated in the text: October 2023
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The information on this site does not replace the advice of a doctor or pharmacist.
Drug information for Galantamine
| Rx or OTC |
Prescription (Rx)?
- This drug is available only with a prescription from a licensed healthcare provider.
- Rx
|
| Drug class |
Cholinesterase Inhibitor |
| Active ingredient |
Galantamine hydrobromide 4 mg/mL
|
| Dosage form |
Solution |
| Route |
Oral |
| Marketing status |
listed in the FDA NDC Directory |
| Company (applicant) |
HIKMA |
| FDA approval |
ANDA 078185Abbreviated New Drug Application (ANDA) – generic drug
Approved January 30, 2009
|
| Manufacturers |
6 labelers list this drug on DailyMed |
| Packages (NDC) |
| Package |
|
4 mg/mL – 100 ml in 1 bottle
NDC 0054-0137-49
|
|
Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.
