Dramamine Tablet, Chewable
FDA Label NDC 63029-906

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 63029-906). 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

Active Ingredient (In Each Tablet)

Meclizine HCl 25 mg

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 hour to 1 hour before activity that may result in nausea

■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

croscarmellose sodium, crospovidone, FD&C red #40 lake, lactose, magnesium stearate, raspberry flavor, silica, sodium saccharin, stearic acid, vanilla flavor

Questions?

1-800-382-7219

Principal Display Panel

All Day Less Drowsy Chewable Formula

Dramamine®

Meclizine HCl 25 mg /Motion Sickness Relief

12 Raspberry Cream Flavored Chewable Tablets (25mg EACH)

Principal Display Panelall Day Less Drowsy Chewable Formuladramamine®meclizine HCl 25 mg /motion Sickness Relief12 Raspberry Cream Flavored Chewable Tablets (25mg Each) (Dramamine All Day Ld Chewable Tabs Raspberry 01)

Principal Display Panelall Day Less Drowsy Chewable Formuladramamine®meclizine HCl 25 mg /motion Sickness Relief12 Raspberry Cream Flavored Chewable Tablets (25mg Each) (Dramamine All Day Ld Chewable Tabs Raspberry 01)

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