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| Product NDC Code | 49483-333 | ||||||||
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| Drug Name | Motion-time chewable |
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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 | Time-Cap Labs, 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 25 mg
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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: take 1 to 2 tablets once daily or as directed by a doctor
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Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients anhydrous lactose, colloidal silicon dioxide, crospovidone, dextrose, FD-C red 40 aluminum lake, magnesium stearate, microcrystalline cellulose, modified corn starch, propylene glycol, raspberry flavor, silicon dioxide, sodium saccharin, stearic acid, talc, vanilla flavor
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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
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Purpose
Information about the drug product’s indications for use.Purpose Antiemetic
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Spl product data elements
Usually a list of ingredients in a drug product.Motion-Time Chewable Meclizine HCl ANHYDROUS LACTOSE CROSPOVIDONE DEXTROSE FD&C RED NO. 40 MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) PROPYLENE GLYCOL RASPBERRY SILICON DIOXIDE SACCHARIN SODIUM STEARIC ACID TALC VANILLA MECLIZINE HYDROCHLORIDE MECLIZINE TCL333
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 HCL Chewable Tablets LABEL COPY
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 trouble urinating due to an enlarged prostate gland glaucoma a breathing problem such as emphysema or chronic bronchitis
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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 take if you are taking sedatives or tranquilizers, without first consulting your doctor
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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.
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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
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Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
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Storage and handling
Information about safe storage and handling of the drug product.Other information store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F) in a dry place use by expiration date on package
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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 give to children under 12 years of age unless directed by a doctor
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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