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| Product NDC Code | 63029-902 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Dramamine orange |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | TABLET, CHEWABLE | ||||||
| RxCUI drug identifier | 309913, 602223 |
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| Application Number | M009 | ||||||
| Labeler Name | Medtech Products 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) Dimenhydrinate 50 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 to prevent motion sickness, the first dose should be taken ½ to 1 hour before starting activity to prevent or treat motion sickness, see below: Adults and children 12 years and over take 1 to 2 tablets every 4-6 hours do not take more than 8 chewable tablets in 24 hours, or as directed by a doctor Children 6 to under 12 years give ½ to 1 tablet every 6-8 hours do not give more than 3 chewable tablets in 24 hours, or as directed by a doctor Children 2 to under 6 years give ½ tablet every 6-8 hours do not give more than 1 ½ chewable tablets in 24 hours, 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 citric acid, aspartame, FD&C yellow #6 aluminum lake, flavors, magnesium stearate, maltodextrin, methacrylic acid copolymer, modified starch, sorbitol
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.Use for prevention and treatment of these symptoms associated with motion sickness nausea vomiting dizziness
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.Dramamine Orange Dimenhydrinate DIMENHYDRINATE 8-CHLOROTHEOPHYLLINE ANHYDROUS CITRIC ACID ASPARTAME FD&C YELLOW NO. 6 ALUMINUM OXIDE MAGNESIUM STEARATE MALTODEXTRIN SORBITOL
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 Dimenhydrinate Tablets/Antiemetic CHEWABLE FORMULA Dramamine ® MOTION SICKNESS RELIEF DUAL ACTION 1. TREATS SYMPTOMS ON THE SPOT 2. PREVENTS NAUSEA, DIZZINESS & VOMITING Convenient Chewable Tablets 8 ORANGE FLAVORED TABLETS (50 mg EACH) PRINCIPAL DISPLAY PANEL Dimenhydrinate Tablets/Antiemetic CHEWABLE FORMULA Dramamine® MOTION SICKNESS RELIEF 8 ORANGE FLAVORED TABLETS (50 mg EACH)
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.Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland
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.Ask a d octor or pharmacist before use if you are taking sedatives or tranquilizers
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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Phenylketonurics: contains phenylalanine 0.84 mg per tablet store at room temperature 68-77ºF (20-25ºC) do not use if carton is opened or if blister is broken or torn see side panel for lot number and expiration date
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 1-800-382-7219
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 marked 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 feedingI f pregnant or breast-feeding, ask a doctor before use.
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 2 years of age unless directed by a doctor Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland Ask a d octor or pharmacist before use if you are taking sedatives or tranquilizers When using this product marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery I f pregnant or breast-feeding, ask a doctor before use. Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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