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| Product NDC Code | 66715-9809 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Dramamine |
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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 | Lil' Drug Store 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 1/2 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 chewable 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 chewable 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 chewable tablet every 6-8 hours do not give more than 1-½ chewable tablets in 24 hours, or as directed by a doctor
| adults and children 12 years and over |
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| children 6 to under 12 years |
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| children 2 to under 6 years |
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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 Dimenhydrinate ASPARTAME ANHYDROUS CITRIC ACID FD&C YELLOW NO. 6 ALUMINUM OXIDE MAGNESIUM STEARATE MALTODEXTRIN METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) STARCH, CORN SORBITOL DIMENHYDRINATE CHLORTHEOPHYLLINE DRA Dramamine, TRAVEL BASIX Dimenhydrinate ANHYDROUS CITRIC ACID ASPARTAME FD&C YELLOW NO. 6 ALUMINUM OXIDE MAGNESIUM STEARATE MALTODEXTRIN METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) STARCH, CORN SORBITOL DIMENHYDRINATE CHLORTHEOPHYLLINE DRA
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.Dramamine Chewable 2ct, Lil' Drug Store - PDP/Package #1 Pharmacist Recommended Brand Dimenhydrinate Tablets/Antiemetic Dramamine ® motion sickness CHEWABLE Dual Action: Prevents & Relieves Nausea, Dizziness and Vomiting 2 Orange Flavored Tablets (50 mg each) Lil' Drug Store ® PDP
Dramamine Chewable 4ct, TRAVEL BASIX - PDP/Package Dramamine ® motion sickness CHEWABLE Dual Action: Prevents & Relieves Nausea,Dizziness and Vomiting 4 Orange Flavored Tablets (50 mg each) [TRAVEL BASIX logo] PDP/Package
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
Repackaged and distributed by: Lil' Drug Store Products, Inc., 1201 Continental Place NE, Cedar Rapids, IA 52402
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 doctor or pharmacist before use if you are taking sedatives or tranquilizers
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 use for children under 2 years of age unless directed by a 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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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? 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 feedingIf pregnant or breast-feeding, ask a doctor before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information Phenylketonurics: contains phenylalanine 0.84 mg per tablet store at room temperature 68°-77°F (20°-25°C) do not use if packet is torn see bottom panel for lot number and expiration date
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 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 doctor 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 If 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