Dramamine
FDA Label NDC 52904-962

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Select Corporation for the product Dramamine (NDC 52904-962). 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 other, active ingredient (in each tablet), purpose, use, warnings, ask a doctor before use if you have, otc - ask doctor/pharmacist, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Dist By:
Medtech Products, Inc. Tarrytown, NY 10591

Product Repackaged and Distributed
with permission of manufacturer by:
Select Corporation Carrollton, TX 75007

Active Ingredient (In Each Tablet)

Dimenhydrinate 50 mg

Purpose

Antiemetic

Use

for prevention and treatment of these symptoms associated with motion sickness:

  • nausea
  • vomiting
  • dizziness

Warnings

Do not give to 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

Otc - Ask Doctor/Pharmacist

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

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a doctor before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

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, see below:
    • 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 1½ chewable tablets in 24 hours, or as directed by a doctor

Other Information

  • Phenylketonurics: contains phenylaline 0.84 mg per tablet
  • store at room tempurature 20°- 25°C (68°-77°F)
  • do not use if pouch is opened
  • see bottom of this panel 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

Principal Display Panel - 50 Mg Tablet Packet Carton

#1
Pharmacist
Recommended
BRAND

DIMENHYDRINATE
TABLETS / ANTIEMETIC

Dramamine®

motion sickness

CHEWABLE

Dual Action:

Prevents & Relieves Nausea,
Dizziness and Vomiting

TO OPEN
PUSH IN TAB AND PULL OUT

25 Packets of 2 Orange Flavor Tablets
(50 mg each)

Principal Display Panel (50 mg Tablet Packet Carton)

Principal Display Panel (50 mg Tablet Packet Carton)

* Please review the disclaimer below.