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| Product NDC Code | 0904-6772 | ||||
|---|---|---|---|---|---|
| Drug Name | Dimenhydrinate |
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| Type | Generic | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET | ||||
| RxCUI drug identifier | 198603 | ||||
| Application Number | M009 | ||||
| Labeler Name | Major Pharmaceuticals | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Overdosage of Dimenhydrinate
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Active ingredient
A list of the active, medicinal ingredients in the drug product.Drug Facts 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 rst dose should be taken one-half to one hour before starting activity ■ adults and children 12 years of age and over: 1 to 2 tablets every 4-6 hours; not to exceed 8 tablets in 24 hours, or as directed by a doctor ■ children 6 to under 12 years of age : 1/2 to 1 tablet every 6-8 hours; not to exceed 3 tablets in 24 hours, or as directed by a doctor ■ children 2 to under 6 years of age : 1/2 tablet every 6-8 hours; not to exceed 1 1/2 tablets in 24 hours, or as directed by a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose
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 for the prevention and treatment of 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.Dimenhydrinate Dimenhydrinate DIMENHYDRINATE CHLORTHEOPHYLLINE CROSCARMELLOSE SODIUM CROSCARMELLOSE DIBASIC CALCIUM PHOSPHATE DIHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE 1006;1006
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.MAJOR ® NDC 0904-6772-12 Compare to the Active Ingredient in DRAMAMINE ® Original Formula* Driminate TM Dimenhydrinate USP, Antiemetic For Nausea, Dizziness and Vomiting from Motion Sickness 12 Tablets 50mg Each Use as Directed Major Label
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.KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION *This product is not manufactured or distributed by Medtech Products Inc., owner of the registered trademark Dramamine®. Distributed by: MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 Questions or comments? Call (800) 616-2471 www.majorpharmaceuticals.com
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 ■ glaucoma ■ a breathing problem such as emphysema or chronic bronchitis ■ 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
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information ■ each tablet contains: calcium 30 mg ■ store in a dry place at 15° – 30°C (59° – 86°F) ■ protect from moisture ■ see end -ap for expiration date and lot number ■ TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
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? 1-800-231-4670
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 ■ use caution 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. .
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.Do not give to children under 2 years of age unless directed by a doctor Ask a doctor before use if you have ■ glaucoma ■ a breathing problem such as emphysema or chronic bronchitis ■ 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 ■ use caution 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 (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