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| Product NDC Code | 80136-378 | ||||
|---|---|---|---|---|---|
| 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 | M009 | ||||
| Labeler Name | NORTHEAST PHARMA | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each tablet) Meclizine HCI 25mg
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 take the first dose 1/2 hour to 1 hour before starting activity Adults and children 12 years of age and over: Take 1 to 2 tablets once daily, or as directed by a doctor Do not exceed 2 tablets in 24 hours.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients colloidal silicon dioxide, D&C yellow #10 lake, lactose monohydrate, magnesium stearate, pregelatinized starch.
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 For the prevention and treatment of these symptoms associated with motion sickness • nausea • vomiting • dizziness
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 Hydrochloride Meclizine HCl LACTOSE MONOHYDRATE SILICON DIOXIDE STARCH, CORN MAGNESIUM STEARATE D&C YELLOW NO. 10 ALUMINUM LAKE MECLIZINE HYDROCHLORIDE MECLIZINE 44;403
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.package label 1
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.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.Questions or comments? 1-800-540-3765
Storage and handling
Information about safe storage and handling of the drug product.Other information • TAMPER EVIDENT: Do not use if imprinted seal under cap is broken or missing. • store at 20-25ºC (68-77ºF); excursions permitted between 15º-30ºC (59º-86ºF) • protect from humidity
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 use in children under 12 years of age unless directed by a doctor. Ask a doctor before use if you have • breathing problems, such as emphysema or chronic bronchitis • glaucoma • difficulty urinating due to an enlarged prostate gland A sk a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product • drowsiness may occur • avoid alcoholic beverages • alcohol, sedatives and tranquilizers may increase drowsiness • use caution when driving a motor vehicle or operating machinery I f pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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