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Motion sickness relief - Medication Information

Product NDC Code 83059-0007
Drug Name

Motion sickness relief

Type Brand
Pharm Class Antiemetic [EPC],
Emesis Suppression [PE]
Active Ingredients
Meclizine hydrochloride 25 mg/1
Route ORAL
Dosage Form TABLET, FILM COATED
RxCUI drug identifier 995666
Application Number M002
Labeler Name Shield Pharmaceuticals Corp
Packages
Package NDC Code Description
83059-0007-1 1 bottle in 1 package (83059-0007-1) / 15 tablet, film coated in 1 bottle
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient (in each liquid-filled capsule) 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 take more than directed take first dose ½ to 1 hour before starting activity adults and children 12 years and over: 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 colloidal silicon dioxide, D&C yellow #10 aluminum 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 nausea, vomiting, or dizziness associated with 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.
Motion Sickness Relief Meclizine HCl SILICON DIOXIDE D&C YELLOW NO. 10 ALUMINUM LAKE LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, CORN 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.
PRINCIPAL DISPLAY PANEL Compare to Dramamine® Less Drowsy active ingredient† LESS DROWSY FORMULA Motion Sickness Relief Meclizine HCl, 25 mg Antiemetic Helps prevent nausea and dizziness due to motion sickness For Ages 12 and Over Motion Sickness Label Motion Sickness Carton

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.
Drug Facts Shield Pharmaceuticals Corp. Carle Place, NY 11514

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 difficulty in urination due to enlargement of the prostate gland a breathing problem such as emphysema or chronic bronchitis

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.
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

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.1(800)222-1222

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Other information TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR SAFETY SEAL UNDER CAP IS BROKEN OR MISSING store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) protect from heat and humidity

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? 1-800-373-6981 (toll-free)

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
When using this product drowsiness may occur n avoid alcoholic beverages alcohol, sedatives, and tranquilizers may increase drowsiness 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.

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.

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