Active Ingredient (In Each Tablet)
Dimenhydrinate 50 mg
Dramamine
FDA Label NDC 67751-170
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Navajo Manufacturing Company Inc. for the product Dramamine (NDC 67751-170). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, use, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if, when using this product, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiemetic
Use
for prevention and treatment of these symptoms associated with motion sickness:
• nausea • vomiting • dizziness
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.
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:
| 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 1/2 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 1/2 chewable tablet every 6-8 hours • do not give more than 1-1/2 chewable tablets in 24 hours, or as directed by a doctor |
Other Information
•
Phenylketonurics: contains phenylalanine 0.75 mg per tablet
• store at room temperature 20°-25°C (68°- 77°F)
• do not use if pouch is opened
• see pouch for lot number and expiration date
Inactive Ingredients
anhydrous citric acid, aspartame, FD&C yellow #6 aluminum lake, flavors, magnesium stearate, maltodextrin, methacrylic acid copolymer, modified starch, sorbitol
Questions Or Comments?
call 1-800-382-7219
Package Labeling:
Dramamine (Dramamine)
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