Amantadine Hydrochloride (Page 5 of 5)
HOW SUPPLIED
Amantadine Hydrochloride Oral Solution USP, 50 mg/5 mL is a colorless to pale yellow, raspberry-flavored oral solution available in:
1 Pint (473 mL) bottles NDC 60432-093-16
Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature].
KEEP TIGHTLY CLOSED
Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).
REFERENCES
1 W.W. Wilson and A.H. Rajput, Amantadine-Dyazide Interaction, Can. Med. Assoc. J. 129:974–975, 1983.
2 D.F. Casey, N. Engl. J. Med. 298:516, 1978.
3 C.D. Berkowitz, J. Pediatr. 95:144, 1979.
Manufactured for:
Wockhardt USA, LLC
Parsippany, NJ 07054
Manufactured By:
Morton Grove Pharmaceuticals, Inc.
Morton Grove, IL 60053
A50-8093-16
REV. 07-18
PRINCIPAL DISPLAY PANEL mL Bottle Label
NDC 60432-093-16
Amantadine
Hydrochloride
Oral Solution, USP
50 mg/5 mL
DO NOT USE IF TAMPER-EVIDENT SEAL
IS BROKEN OR MISSING.
Rx Only
NET: 1 Pint (473 mL)
Amantadine Hydrochloride Oral Solution Label
AMANTADINE HYDROCHLORIDE amantadine hydrochloride solution | ||||||||||||||||||||
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Labeler — Morton Grove Pharmaceuticals, Inc. (801897505) |
Registrant — Morton Grove Pharmaceuticals, Inc. (801897505) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Morton Grove Pharmaceuticals, Inc. | 801897505 | ANALYSIS (60432-093), LABEL (60432-093), MANUFACTURE (60432-093), PACK (60432-093) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Moehs Catalana S.L. | 460021629 | API MANUFACTURE (60432-093) |
Revised: 12/2018 Morton Grove Pharmaceuticals, Inc.
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