Active Ingredient (In Each Tablet)
Meclizine HCl 25 mg
Dramamine Tablet, Chewable
FDA Label NDC 63029-913
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Medtech Products Inc. for the product Dramamine (NDC 63029-913). 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 give to, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are taking, 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 Give To
children under 12 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
■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 overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
■to prevent motion sickness, take first dose ½ to 1 hour before activity
■to treat motion sickness, take at first signs of symptoms
■adults and children 12 years and over: 1 to 2 tablets once daily, or as directed by a doctor
Other Information
■store at room temperature 20°–25°C (68°-77°F)
Inactive Ingredients
corn starch, croscarmellose sodium, crospovidone, flavors, lactose monohydrate, magnesium stearate, maltodextrin, propylene glycol, saccharin sodium, silicon dioxide, stearic acid, sucrose, tricalcium phosphate.
Questions?
1-800-382-7219
Dramamine.com
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All Day Less Drowsy Chewable Formula
Dramamine®
Meclizine Hydrochloride | Antiemetic | 25 mg /Motion Sickness
12 Raspberry Cream Flavored Tablets (25 mg EACH)
Principal Display Panelall Day Less Drowsy Chewable Formuladramamine®meclizine Hydrochloride | Antiemetic | 25 mg /motion Sickness12 Raspberry Cream Flavored Tablets (25 mg Each) (Dramamine All Day Ld Chewable Tablets Raspberry 01)
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