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| Product NDC Code | 24689-138 | ||||
|---|---|---|---|---|---|
| Drug Name | Meclizine hydrochloride |
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| Type | Generic | ||||
| 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 | 995624, 995666 |
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| Application Number | M009 | ||||
| Labeler Name | APNAR PHARMA LP | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient (in each tablet) 12.5mg tablet: Meclizine HCL.... 12.5 mg 25mg 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 Meclizine HCL 12.5mg tablet : Dosage should be taken one hour before travel starts -adults & children 12 years and over: take 2 or 4 tablets once daily or as directed by a doctor Meclizine HCL 25mg tablet: Dosage should be taken one hour before travel starts -adults & children 12 years and over: take 1 or 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 Magnesium stearate, microcrystalline cellulose,silicon dioxide, lactose monohydrate
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 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.Meclizine Hydrochloride Meclizine Hydrochloride MECLIZINE HYDROCHLORIDE MECLIZINE MAGNESIUM STEARATE SILICON DIOXIDE LACTOSE MONOHYDRATE MICROCRYSTALLINE CELLULOSE A;C4 Meclizine Hydrochloride Meclizine Hydrochloride SILICON DIOXIDE MECLIZINE HYDROCHLORIDE MECLIZINE MICROCRYSTALLINE CELLULOSE MAGNESIUM STEARATE LACTOSE MONOHYDRATE White to off white AM7
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 : 24689-138-01 Meclizine Hydrochloride Tablets 12.5 mg Antiemetic 100 Tablets NDC : 24689-139-01 Meclizine Hydrochloride Tablets 25 mg Antiemetic 100 Tablets Meclizine HCl 12.5 mg tablets -100s Meclizine HCl 25 mg _label-100s
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.Rev.: 05/2022 Made in USA Manufactured by: APNAR PHARMA LLP East Windsor, NJ 08520
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)
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 20°to 25°C (68°to 77°F), excursions permitted between 15°to 30°C (59°to 86°F) [see USP controlled room temperature]
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.Do not use in children under 12 years of age unless directed by a doctor Do not take this product, unless directed by a doctor, if you have Glaucoma A breathing problem such as emphysema or chronic bronchitis Trouble urination due to an enlarged prostate gland Do not take this product if you are taking Sedatives or tranquilizers, without first consulting your doctor. 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
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