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| Product NDC Code | 43063-804 | ||||||||||||
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| Drug Name | Meclizine 25 |
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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 | M009 | ||||||||||||
| Labeler Name | PD-Rx 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 Ingredients (in each chewable tablet) Meclizine 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 1 hour befor 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: | Take 1 or 2 tablets once daily, or as directed by doctor. |
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.Indications and Usage prevents and treats nausea, vomiting, 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 25 MECLIZINE HYDROCHLORIDE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE CROSCARMELLOSE SODIUM MECLIZINE HYDROCHLORIDE MECLIZINE DEXTROSE FD&C RED NO. 40 SACCHARIN SODIUM SACCHARIN STEARIC ACID SILICON DIOXIDE LIGHT PINK COLOR 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.PRINCIPAL DISPLAY PANEL - 25 mg Bottle Label Antiemetic Each chewable tablet contains: Meclizine HCl 25 mg Store at 68°-77°F (20°-25°C) Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing. image
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
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.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
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.Do not take if you are taking sedatives or tranquilizers, without first consulting your 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. 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? Adverse drug event call (866) 562-2756 (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 avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask 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 Meclizine 25mg are supplied as chewable pink round scored tablets with PH 051 embossed on them. Supplied in bottles of 6, 12 , 20, 30 and 100 chewable tablets.
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 avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery If pregnant or breast-feeding, ask 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