Meclizine Hydrochloride Tablets USP, 12.5 mg and 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 tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system.

Meclizine hydrochloride tablets are 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.

To report SUSPECTED ADVERSE REACTIONS, contact Epic Pharma, LLC at

1-888-374-2791 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Meclizine Hydrochloride Tablets, USP are available as follows:

12.5 mg, blue, modified oval-shaped tablets, de-bossed “ Є12” on one side and plain on the other side. They are supplied as follows:

NDC 42806-012-01 in bottles of 100

NDC 42806-012-10 in bottles of 1000

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 42806-014-01 in bottles of 100

NDC 42806-014-10 in bottles of 1000

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

Rev.05-2018-00

MF012REV05/18

OE1035

DRUG: Meclizine Hydrochloride

GENERIC: Meclizine Hydrochloride

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-0421-0

NDC: 70518-0421-1

COLOR: blue

SHAPE: OVAL

SCORE: No score

SIZE: 10 mm

IMPRINT: E12

PACKAGING: 90 in 1 BOTTLE, PLASTIC

PACKAGING: 30 in 1 BOTTLE PLASTIC

ACTIVE INGREDIENT(S):

• MECLIZINE HYDROCHLORIDE 12.5mg in 1

INACTIVE INGREDIENT(S):

• CROSCARMELLOSE SODIUM
• MAGNESIUM STEARATE
• FD&C BLUE NO. 1
• CELLULOSE, MICROCRYSTALLINE
• LACTOSE MONOHYDRATE

Remedy_Label

MM2