Meclizine Hydrochloride Tablets USP, 25 mg Rx Only

Chemically, meclizine hydrochloride is 1-( p-chloro-α-phenylbenzyl)-4-( m-methylbenzyl) piperazine dihydrochloride monohydrate.

C ₂₅H ₂₇CIN ₂·2HCl·H ₂0 M.W. 481.89

Meclizine hydrochloride tablets, USP are available in two different strengths, 12.5 mg and 25 mg. Inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium and magnesium stearate. The 12.5 mg tablet also contains FD&C Blue #1 Aluminum Lake.

Meclizine hydrochloride is an antihistamine that shows marked protective activity against nebulized histamine and lethal doses of intravenously injected histamine in guinea pigs. It has a marked effect in blocking the vasodepressor response to histamine, but only a slight blocking action against acetylcholine. Its activity is relatively weak in inhibiting the spasmogenic action of histamine on isolated guinea pig ileum.

Meclizine hydrochloride is contraindicated in individuals who have shown a previous hypersensitivity to it.

Since drowsiness may, on occasion, occur with use of this drug, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery.

Patients should avoid alcoholic beverages while taking this drug.

Due to its potential anticholinergic action, this drug should be used with caution in patients with asthma, glaucoma, or enlargement of the prostate gland.

Anaphylactoid reaction, drowsiness, dry mouth, headache, fatigue, vomiting and, on rare occasions, blurred vision have been reported.

25 mg, white, modified oval-shaped tablets, de-bossed “ Є14” on one side and plain on the other side. They are supplied as follows:

NDC 12634-424-00 Bottles of 10

NDC 12634-424-01 Bottles of 100

NDC 12634-424-09 Bottles of 35

NDC 12634-424-12 Bottles of 120

NDC 12634-424-18 Bottles of 180

NDC 12634-424-40 Bottles of 40

NDC 12634-424-42 Bottles of 42

NDC 12634-424-45 Bottles of 45

NDC 12634-424-50 Bottles of 50

NDC 12634-424-52 Blister Pack of 12

NDC 12634-424-54 Blister Pack of 14

NDC 12634-424-57 Blister Pack of 20

NDC 12634-424-59 Blister Pack of 30

NDC 12634-424-60 Bottles of 60

NDC 12634-424-61 Blister Pack of 10

NDC 12634-424-63 Blister Pack of 3

NDC 12634-424-66 Blister Pack of 6

NDC 12634-424-67 Blister Pack of 7

NDC 12634-424-69 Blister Pack of 9

NDC 12634-424-71 Bottles of 30

NDC 12634-424-74 Bottles of 24

NDC 12634-424-78 Bottles of 28

NDC 12634-424-79 Bottles of 25

NDC 12634-424-80 Bottles of 20

NDC 12634-424-81 Bottles of 21

NDC 12634-424-82 Bottles of 12

NDC 12634-424-84 Bottles of 14

NDC 12634-424-85 Bottles of 15

NDC 12634-424-90 Bottles of 90

NDC 12634-424-91 Blister Pack of 1

NDC 12634-424-92 Bottles of 2

NDC 12634-424-93 Bottles of 3

NDC 12634-424-94 Bottles of 4

NDC 12634-424-95 Bottles of 5

NDC 12634-424-96 Bottles of 6

NDC 12634-424-97 Bottles of 7

NDC 12634-424-98 Bottles of 8

NDC 12634-424-99 Bottles of 9

Store at 20º to 25ºC (68 to 77ºF) [See USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container as defined in the USP, with a child-resistant closure, as required.

Manufactured by:

Epic Pharma, LLC

Laurelton, NY 11413

Manufactured in USA

Revised January 2016

MF012REV01/16

OE1035

Repackaged & Distributed by:

Apotheca Inc.

Phoenix, AZ 85006

Meclizine Hydrochloride Tablets USP, 25 mg

25 mg

Rx Only

30 Tablets

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