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1 INDICATIONS AND USAGE Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults. Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults ( 1 ).
Amneal Pharmaceuticals LLC
OVAL YELLOW AN 442
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
MECLIZINE Hydrochloride Tablets USP, 12.5 mg are supplied as light blue colored, oval shaped tablets with “AN 441” debossed on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 65162-441-03 Bottles of 100: NDC 65162-441-10 Bottles of 500: NDC 65162-441-50 Bottles of 1000: NDC 65162-441-11
MECLIZINE Hydrochloride Tablets USP, 25 mg are supplied as light yellow colored, oval shaped tablets with “AN 442” debossed on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 65162-442-03 Bottles of 100: NDC 65162-442-10 Bottles of 500: NDC 65162-442-50 Bottles of 1000: NDC 65162-442-11
MECLIZINE Hydrochloride Tablets USP, 50 mg are supplied as white, oval shaped, partially bisected tablets with “AN 444” debossed on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 65162-444-03 Bottles of 100: NDC 65162-444-10 Bottles of 500: NDC 65162-444-50 Bottles of 1000: NDC 65162-444-11 16.2 Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. Keep this and all medication out of the reach of children.
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