Dramamine Chewable Dimenhydrinate Tablet, Chewable
FDA Label NDC 50269-525

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Jc World Bell Wholesale Co., Inc. for the product Dramamine Chewable Dimenhydrinate (NDC 50269-525). 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 drug facts, active ingredient (in each tablet), purpose, use, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

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 givetochildren 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

  • marked 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, the first dose should be taken ½ 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 ½ 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 ½ chewable tablet every 6-8 hours
    • do not give more than 1 ½ chewable tablets
      in 24 hours, or as directed by a doctor

Other Information

  • Phenylketonurics: contains phenylalanine 0.84 mg per tablet
  • store at room temperature 20-25°C (68-77°F)
  • see side panel for lot number and expiration date

Inactive Ingredients

anhydrous-citric-acid, aspartame, FD&C yellow no. 6 aluminum lake, flavors, magnesium stearate, maltodextrin, methacrylic acid copolymer, modified starch, sorbitol

Questions?

1-800-382-7219 Dramamine.com

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