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| Product NDC Code | 70985-009 | ||||
|---|---|---|---|---|---|
| Drug Name | Meclizine hcl |
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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 | 995624 | ||||
| Application Number | M009 | ||||
| Labeler Name | Drug Ocean LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients (in each tablet) Meclizine HCl, USP 12.5 mg
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.Directions dosage should be taken one hour before travel starts adults and children 12 years and over take 2 or 4 tablets once daily or as directed by a doctor
| adults and children 12 years and over | take 2 or 4 tablets once daily or as directed by a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose
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.Uses: prevents and treats nausea, vomiting, or dizziness due to motion sickness.
Purpose
Information about the drug product’s indications for use.Purpose Antiemetic
Spl product data elements
Usually a list of ingredients in a drug product.Meclizine HCl MECLIZINE HYDROCHLORIDE SILICON DIOXIDE CROSPOVIDONE LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE MECLIZINE HYDROCHLORIDE MECLIZINE White to Off White AB;12
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 - 12.5 mg Tablet Label NDC 70985-009-01 Meclizine HCl 12.5 mg 100 Tablets Distributed by: Drug Ocean LLC, 1 Bridge Plaza, North Central Road, 6th Floor, Suite 675 Fort Lee, NJ 07024 Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.) Mumbai 400 030, India ORG 12/23 12.5
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.TAMPER EVIDENT: DO NOT USE IF FOIL SEAL UNDER CAP, PRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING Distributed by: Drug Ocean LLC, 1 Bridge Plaza, North Central Road, 6th Floor, Suite 675, Fort Lee, NJ 07024 Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.) Mumbai 400 030, India ORG 12/23
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Do not use in children under 12 years of age unless directed by a doctor.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Call 1-844-200-6566 Monday to Friday 9 AM to 5 PM EST
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using product do not exceed recommended dosage may cause drowsiness alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks use caution when driving a motor vehicle or operating machinery
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding , ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other Information store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
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: Do not take this product, unless directed by a doctor, if you have Glaucoma A breathing problem such as emphysema or chronic bronchitis Trouble urinating due to an enlarged 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