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| Product NDC Code | 63187-996 | ||||||||||||
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| Drug Name | Meclizine hydrochloride |
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| Type | Brand | ||||||||||||
| Pharm Class | Antiemetic [EPC], Emesis Suppression [PE] |
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| Active Ingredients |
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| Route | ORAL | ||||||||||||
| Dosage Form | TABLET | ||||||||||||
| RxCUI drug identifier | 995666 | ||||||||||||
| Application Number | ANDA040659 | ||||||||||||
| Labeler Name | Proficient Rx LP | ||||||||||||
| Packages |
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Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.ADVERSE REACTIONS Drowsiness, dry mouth and, on rare occasions, blurred vision have been reported.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.CLINICAL PHARMACOLOGY 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.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.CONTRAINDICATIONS Meclizine Hydrochloride is contraindicated in individuals who have shown a previous hypersensitivity to it.
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.DESCRIPTION Chemically, Meclizine HCl is 1-( p -chloro-α-phenylbenzyl)-4-( m -methylbenzyl) piperazine dihydrochloride monohydrate. C 25 H 27 ClN 2 . 2HCl . H 2 O 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%). Structure of Meclizine HCl
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.DOSAGE AND ADMINISTRATION Motion Sickness The initial dose of 25 to 50 mg of Meclizine HCI should be taken one hour prior to travel for protection against motion sickness. Thereafter, the dose may be repeated every 24 hours for the duration of the journey.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.INDICATIONS AND USAGE For the management of nausea and vomiting, and dizziness associated with motion sickness.
Spl product data elements
Usually a list of ingredients in a drug product.MECLIZINE HYDROCHLORIDE Meclizine Hydrocloride Meclizine Hydrochloride Meclizine Silicon Dioxide Croscarmellose Sodium Lactose Monohydrate Magnesium Stearate MICROCRYSTALLINE CELLULOSE D&c Yellow No. 10 Aluminum Oxide TL121
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL NDC 63187-996-20 Meclizine Hydrochloride Tablets, USP 25 mg 20 Tablets Rx Only Each tablet Contains 25 mg of meclizine HCl DOSAGE AND USE See accompanying prescribing information MOTION SICKNESS: 25 mg to 50 mg daily. Dispense in tight, light-resistant containers (USP). Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. 63187-996-20
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.HOW SUPPLIED Meclizine HCI Tablets, USP are available in the following strengths and package sizes: 25 mg (Yellow, oval-shaped, scored, debossed with TL121) Bottles of 10 NDC 63187-996-10 Bottles of 20 NDC 63187-996-20 Bottles of 30 NDC 63187-996-30 Bottles of 60 NDC 63187-996-60 Bottles of 90 NDC 63187-996-90 Store at 20-25°C (68-77°F) (See USP Controlled Room Temperature]. Manufactured By: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA. Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 Revised 03/11
Precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTIONS 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.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.WARNINGS 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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API