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| Product NDC Code | 16103-387 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Meclizine |
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| Type | Brand | ||||||
| Pharm Class | Antiemetic [EPC], Emesis Suppression [PE] |
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| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | TABLET, CHEWABLE | ||||||
| RxCUI drug identifier | 995632 | ||||||
| Application Number | part336 | ||||||
| Labeler Name | Pharbest Pharmaceuticals, Inc. | ||||||
| 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) Meclizine HCl 25mg
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 doage should be taken one hour before travel starts Adults and children 12 years and over take 1 or 2 tablets once daily or as directed by doctor
| Adults and children 12 years and over |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Croscarmellose sodium, dextrose, FD&C Red#40, raspberry flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium saccharine, 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 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 Meclizine HCl 25mg MECLIZINE HYDROCHLORIDE MECLIZINE CROSCARMELLOSE SODIUM DEXTROSE FD&C RED NO. 40 MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SILICON DIOXIDE SACCHARIN SODIUM STEARIC ACID RASPBERRY LIGHT PINK COLOR ROUND TABLET PH051
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.PHARBEST NDC 16103-387-11 Manufactured in the USA Chewable, Once-A-Day Protection *Compare to the active ingredient in Bonine ® MECLIZINE CHEWABLE Raspberry Flavor Meclizine HCl 25mg Antiemetic • Motion Sickness • Nausea • Vomiting 1000 TABLETS Meclizine 25 mg Chewable Tablet Product Label
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? (866) 562-2756 (Mon - Fri, 8AM - 4PM EST)
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 feedingIf 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 safety seal under cap is broken or missing store at 20°-25°C (68°-77°F)
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. Do not take this product unless directed by a doctor if you have glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating 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. 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