Label: MECLIZINE HYDROCHLORIDE- meclizine hydrocloride tablet
Contains inactivated NDC Code(s)
NDC Code(s): 10544-081-30
- Packager: Blenheim Pharmacal, Inc.
- This is a repackaged label.
- Source NDC Code(s): 59746-121
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated March 16, 2015
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Meclizine Hydrochloride is an antihistamine which 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.
- INDICATIONS AND USAGE
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.
PREGNANCY, Teratogenic Effects
Pregnancy Category B. Reproduction studies in rats have shown cleft palates at 25-50 times the human dose. Epidemiological studies in pregnant women, however, do not indicate that medicine increases the risk of abnormalities when administered during pregnancy. Despite the animal findings, it would appear that the possibility of fetal harm is remote. Nevertheless, meclizine, or any other medication, should be used during pregnancy only if clearly necessary.
Clinical studies establishing safety and effectiveness in children have not been done; therefore, usage is not recommended in children under 12 years of age.
- ADVERSE REACTIONS
- DOSAGE AND ADMINISTRATION
Meclizine HCI Tablets, USP are available in the following strengths and package sizes:
12.5 mg (Blue, oval-shaped, scored, debossed with TL122)
Bottles of 100 NDC 59746-122-06
Bottles of 1000 NDC 59746-122-10
25 mg (Yellow, oval-shaped, scored, debossed with TL121)
Bottles of 100 NDC 59746-121-06
Bottles of 1000 NDC 59746-121-10
Store at 20-25°C (68-77°F) (See USP Controlled Room Temperature].
Jubilant Cadista Pharmaceuticals Inc.
Salisbury, MD 21801, USA.
Chemically, Meclizine HCl is 1-( p-chloro-α-phenylbenzyl)-4-( m-methylbenzyl) piperazine dihydrochloride monohydrate.
C 25H 27ClN 2. 2HCl . H 2O M .W . 481 .88
Meclizine HCI Tablets, USP are available in two different strengths: 12.5 mg and 25 mg. In addition each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Croscarmellose Sodium, Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose. Also, Meclizine HCI Tablets USP, 12.5 mg contains FD&C Blue #1 Aluminum Lake (11-13%) and Meclizine HCI Tablets USP, 25 mg contains D&C Yellow #10 Aluminum Lake (15-20%).
- Principal Display Panel
INGREDIENTS AND APPEARANCE
meclizine hydrocloride tablet
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10544-081(NDC:59746-121) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE 25 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) ALUMINUM OXIDE (UNII: LMI26O6933) Product Characteristics Color yellow Score 2 pieces Shape OVAL Size 13mm Flavor Imprint Code TL121 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10544-081-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 08/07/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040659 08/01/2012 Labeler - Blenheim Pharmacal, Inc. (171434587) Registrant - Blenheim Pharmacal, Inc. (171434587) Establishment Name Address ID/FEI Business Operations Blenheim Pharmacal, Inc. 171434587 repack(10544-081)