Label: MECLIZINE HYDROCHLORIDE tablet
- NDC Code(s): 61919-146-20, 61919-146-30
- Packager: DIRECT RX
- 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
Drug Label Information
Updated April 12, 2023
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- Official Label (Printer Friendly)
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DESCRIPTION SECTION
Chemically, Meclizine HCl is 1-(p-chloro-α-phenylbenzyl)-4-(m-methylbenzyl) piperazine dihydrochloride monohydrate.
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%).
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CLINICAL PHARMACOLOGY SECTION
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 & USAGE SECTION
- CONTRAINDICATIONS SECTION
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WARNINGS SECTION
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.
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PRECAUTIONS SECTION
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.
Pediatric Use
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 SECTION
- DOSAGE & ADMINISTRATION SECTION
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HOW SUPPLIED SECTION
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].Manufactured By:
Jubilant Cadista Pharmaceuticals Inc.
Salisbury, MD 21801, USA.Revised 03/11
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MECLIZINE HYDROCHLORIDE
meclizine hydrochloride tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-146(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 CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) ALUMINUM OXIDE (UNII: LMI26O6933) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 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:61919-146-20 20 in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2014 2 NDC:61919-146-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040659 01/01/2014 Labeler - DIRECT RX (079254320) Establishment Name Address ID/FEI Business Operations DIRECT RX 079254320 relabel(61919-146) , repack(61919-146)