Dramamine Chewable Orange Tablet, Chewable
FDA Label NDC 63029-915

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 Chewable Orange (NDC 63029-915). 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, purpose, use, do not give, 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

  • take first dose 1/2 to 1 hour before starting activity
  • 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

anhydrous citric acid, ascorbic acid, butylated hydroxytoluene, corn starch, croscarmellose sodium, crospovidone, FD&C yellow #6 lake, lactose monohydrate, magnesium stearate, maltodextrin, natural orange flavor, natural pink lemonade flavor, saccharin sodium, silicon dioxide, stearic acid.

Questions Or Comments?

Call 1-800-382-7219

Dramamine.com

Principal Display Panel

Dramamine®

MECLIZINE HYDROCHLORIDE | ANTIEMETIC | 25 MG
motion sickness
CHEWABLE
Dual Action:
Prevents & Relieves Nausea,
Dizziness and Vomiting
8 ORANGE-FLAVORED CHEWABLE TABLETS

Principal Display Paneldramamine®meclizine Hydrochloride | Antiemetic | 25 mgmotion Sicknesschewabledual Action:prevents & Relieves Nausea,dizziness And Vomiting8 Orange-flavored Chewable Tablets (Dramamine Chewable Orange Meclizine 63029 915 01)

Principal Display Paneldramamine®meclizine Hydrochloride | Antiemetic | 25 mgmotion Sicknesschewabledual Action:prevents & Relieves Nausea,dizziness And Vomiting8 Orange-flavored Chewable Tablets (Dramamine Chewable Orange Meclizine 63029 915 01)

Principal Display Paneldramamine®meclizine Hydrochloride | Antiemetic | 25 mgmotion Sicknesschewabledual Action:prevents & Relieves Nausea,dizziness And Vomiting8 Orange-flavored Chewable Tablets (Dramamine Chewable Orange Meclizine 63029 915 02)

Principal Display Paneldramamine®meclizine Hydrochloride | Antiemetic | 25 mgmotion Sicknesschewabledual Action:prevents & Relieves Nausea,dizziness And Vomiting8 Orange-flavored Chewable Tablets (Dramamine Chewable Orange Meclizine 63029 915 02)

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