Dramamine Powder
FDA Label NDC 63029-912

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 63029-912). 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 pack), 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 Pack)

Meclizine HCl 50 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

■take dose ½ to 1 hour before starting activity

■adults and children 12 years and over: place 1 packet on tongue once daily, or as directed by a doctor

Other Information

■PHENYLKETONURICS: contains phenylalanine 1.68 mg per packet.

■store at room temperature 20°–25°C (68°-77°F)

Inactive Ingredients

anhydrous citric acid, ascorbic acid, aspartame, butylated hydroxytoluene, corn starch, guar gum, maltodextrin, mannitol, microcrystalline cellulose, natural orange flavor, natural pink lemonade flavor, silicon dioxide, sorbitol.

Questions?

1-800-382-7219

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Dramamine®

Meclizine Hydrochloride | Antiemetic | 50 mg

Motion Sickness

Less Drowsy Powder

4 Orange Flavored Powder Packs (50 MG EACH)

Dramamine®meclizine Hydrochloride | Antiemetic | 50 mgmotion Sicknessless Drowsy Powder4 Orange Flavored Powder Packs (50 mg Each) (Dramamine Less Drowsy Powder Orange 01)

Dramamine®meclizine Hydrochloride | Antiemetic | 50 mgmotion Sicknessless Drowsy Powder4 Orange Flavored Powder Packs (50 mg Each) (Dramamine Less Drowsy Powder Orange 01)

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