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Dramamine original formula - Medication Information

Product NDC Code 63029-901
Drug Name

Dramamine original formula

Type Brand
Active Ingredients
Dimenhydrinate 50 mg/1
Route ORAL
Dosage Form TABLET
RxCUI drug identifier 198603,
201716
Application Number M009
Labeler Name Medtech Products Inc.
Packages
Package NDC Code Description
63029-901-01 3 blister pack in 1 box (63029-901-01) / 12 tablet in 1 blister pack
63029-901-02 1 bottle in 1 box (63029-901-02) / 12 tablet in 1 bottle
63029-901-03 1 pouch in 1 carton (63029-901-03) / 2 tablet in 1 pouch
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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 tables every 4-6 hours do not take more than 8 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 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 tablets in 24 hours, or as directed by a doctor
Adults and children 12 years and overtake 1 to 2 tables every 4-6 hours do not take more than 8 tablets in 24 hours, or as directed by a doctor
Children 6 to under 12 yearsgive ½ to 1 tablet every 6-8 hours do not give more than 3 tablets in 24 hours, or as directed by a doctor
Children 2 to under 6 yearsgive ½ tablet every 6-8 hours do not give more than 1 ½ tablets in 24 hours, or as directed by a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, lactose, 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.
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 Original Formula Dimenhydrinate DIMENHYDRINATE 8-CHLOROTHEOPHYLLINE SILICON DIOXIDE CROSCARMELLOSE SODIUM LACTOSE, UNSPECIFIED FORM MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE

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 Dramamine ® motion sickness Original Dimenhydrinate tablets/antiemetic 12 tablets (50 mg each) Dramamine® motion sickness Original Dimenhydrinate tablets/antiemetic 12 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 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. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Other information store at room temperature 20-25ºC (68-77ºF)

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 Dramamine.com

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 dizziness be careful when driving a motor vehicle or operating machinery

Pregnancy or breast feeding

Pregnancy or Breast feeding
If 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 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 dizziness 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 overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

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