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| Product NDC Code | 71335-1215 | ||||||||||||||||||||||
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| 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 | Bryant Ranch Prepack | ||||||||||||||||||||||
| 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 1 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, 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, UNSPECIFIED FORM FD&C RED NO. 40 MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SILICON DIOXIDE SACCHARIN SODIUM STEARIC ACID 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.Meclizine 25MG Chewable Label Image
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? Adverse drug event call (800) 687-0176 (M - F, 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 drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful 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.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.HOW SUPPLIED Product: 71335-1215 NDC: 71335-1215-0 120 TABLET, CHEWABLE in a BOTTLE NDC: 71335-1215-1 30 TABLET, CHEWABLE in a BOTTLE NDC: 71335-1215-2 20 TABLET, CHEWABLE in a BOTTLE NDC: 71335-1215-3 25 TABLET, CHEWABLE in a BOTTLE NDC: 71335-1215-4 40 TABLET, CHEWABLE in a BOTTLE NDC: 71335-1215-5 60 TABLET, CHEWABLE in a BOTTLE NDC: 71335-1215-6 90 TABLET, CHEWABLE in a BOTTLE NDC: 71335-1215-7 8 TABLET, CHEWABLE in a BOTTLE NDC: 71335-1215-8 14 TABLET, CHEWABLE in a BOTTLE NDC: 71335-1215-9 10 TABLET, CHEWABLE in a BOTTLE
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 room temperature 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 for children under 12 years of age unless directed by a doctor. Do not take unless directed by a doctor if you have glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis Do not take if you are taking sedatives or tranquilizers, without first consulting your doctor. When using this product do not exceed recommended dosage drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful 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