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Meclizine hydrochloride - Medication Information

Product NDC Code 0536-1299
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, CHEWABLE
RxCUI drug identifier 995632
Application Number M009
Labeler Name Rugby Laboratories
Packages
Package NDC Code Description
0536-1299-01 100 tablet, chewable in 1 bottle (0536-1299-01)
0536-1299-10 1000 tablet, chewable in 1 bottle (0536-1299-10)
Check if available Online

Overdosage of Meclizine Hydrochloride

Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Drug Facts 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  Dosage should be taken one hour before travel starts adults and children 12 years of age and over chew 1 to 2 tablets once daily, or as directed by a doctor children under 12 years of age do not give this product to children under 12 years of age unless directed by a doctor
adults and children 12 years of age and over chew 1 to 2 tablets once daily, or as directed by a doctor
children under 12 years of age do not give this product to children under 12 years of age unless directed by a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Croscarmellose Sodium, Crospovidone, FD&C Red #40 Lake, French Vanilla Flavor, Lactose, Magnesium Stearate, Raspberry Flavor, Silica, Sodium Saccharin, Stearic Acid

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 Hydrochloride Meclizine Hydrochloride CROSPOVIDONE VANILLA MAGNESIUM STEARATE RASPBERRY STEARIC ACID SILICON DIOXIDE FD&C RED NO. 40 MECLIZINE HYDROCHLORIDE MECLIZINE LACTOSE MONOHYDRATE SACCHARIN SODIUM CROSCARMELLOSE SODIUM Rosy 5172

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.
Rugby NDC 0536-1299-10 Compare to the active ingredient in Bonine®* Meclizibe 25 mg Antiemetic 1000 Chewable Tablets Rugby 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.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by Wellspring Pharmaceutical Corporation, owner of the registered trademark Bonine®. Distributed by: RUGBY® LABORATORIES Indianapolis, IN 46268 www.rugbylaboratories.com

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  a breathing problem such as emphysema or chronic bronchitis  trouble 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 in 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.

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Other information  Store in a dry place at 15°-30°C (59°-86°F)  keep lid tightly closed

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? 1-800-645-2158

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  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 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.
Do not use in children under 12 years of age unless directed by a doctor Ask a doctor before use if you have  glaucoma  a breathing problem such as emphysema or chronic bronchitis  trouble 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  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 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 (1-800-222-1222).

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