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Meclizine hydrochloride - Medication Information

Product NDC Code 80136-779
Drug Name

Meclizine hydrochloride

Type Brand
Pharm Class Antiemetic [EPC],
Emesis Suppression [PE]
Active Ingredients
Meclizine hydrochloride 25 mg/1
Route ORAL
Dosage Form TABLET, CHEWABLE
RxCUI drug identifier 995632
Application Number M009
Labeler Name NORTHEAST PHARMA
Packages
Package NDC Code Description
80136-779-01 100 tablet, chewable in 1 bottle (80136-779-01)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient (in each chewable 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 do not exceed recommended dose dosage should be taken one hour before travel starts chew or crush tablets completely before swallowing;do not swallow tablets whole adults and children 12 years and over: take 1 to 2 tablets once daily or as directed by a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients corn starch, FD&C red #40 aluminum lake, flavor, lactose anhydrous, magnesium stearate, saccharin sodium, 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 HCl STARCH, CORN FD&C RED NO. 40 ANHYDROUS LACTOSE MAGNESIUM STEARATE SACCHARIN SODIUM SILICON DIOXIDE MECLIZINE HYDROCHLORIDE MECLIZINE 44;404

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 1

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
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 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.
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use for children under 12 years of age unless directed by a 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.
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

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 this product alcohol, sedatives, and tranquilizers may increase drowsiness drowsiness may occur avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery

Pregnancy or breast feeding

Pregnancy or Breast feeding
If 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 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 for 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 alcohol, sedatives, and tranquilizers may increase drowsiness drowsiness may occur avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery If 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