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Meclizine hydrochloride - Medication Information

Product NDC Code 24689-146
Drug Name

Meclizine hydrochloride

Type Generic
Pharm Class Antiemetic [EPC],
Emesis Suppression [PE]
Active Ingredients
Meclizine hydrochloride 25 mg/1
Route ORAL
Dosage Form TABLET
RxCUI drug identifier 995666
Application Number M009
Labeler Name APNAR PHARMA LP
Packages
Package NDC Code Description
24689-146-01 100 tablet in 1 bottle (24689-146-01)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient (in each tablet) Meclizine HCL 25 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 to prevent motion sickness, take the first dose one hour before starting activity not for frequent or prolonged use except on the advice of a doctor do not exceed recommended dose Adults and children 12 years of age and older: Take 1-2 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: D&C yellow # 10 lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, colloidal silicon dioxide.

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 Hydrochloride SILICON DIOXIDE LACTOSE MONOHYDRATE D&C YELLOW NO. 10 CELLULOSE, MICROCRYSTALLINE MAGNESIUM STEARATE MECLIZINE HYDROCHLORIDE MECLIZINE AM4

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.
NDC 24689-146-01 Meclizine HCL 25 mg Antiemetic 100 Tablets Meclizine HCl 25 mg YELLOW _label

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.
Comapre to active ingredient in DRAMAMINE ® ALL DAY LESS DROWSY* *This product is not manufactured or distributed by the owner of registered trademark of DRAMAMINE ® MADE IN USA Manufactured by: APNAR PHARMA LLP East Windsor, NJ 08520 Rev.:10/2022

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? Call 1-855-642-2594

Storage and handling

Information about safe storage and handling of the drug product.
Other information store at room temperature 15˚-30˚C (59˚-86˚F) protect from humidity

Boxed warning

Information about contraindications or serious warnings, particularly those that may lead to death or serious injury.
Tamper evident:Do not use if safety seal is broken or missing

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 • glaucoma • breathing problems, such as emphysema or chronic bronchitis • difficulty urinating due to an enlarged prostate gland Ask 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 If pregnant or breast-feeding ,ask a health professional before use.

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