Dramamine Less Drowsy Meclizine Hydrochloride Tablet
FDA Label NDC 50269-526

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 Less Drowsy Meclizine Hydrochloride (NDC 50269-526). 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, 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, 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)

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 tranquilzers.

When Using This Product

  • drawsiness 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 lactose, corn starch, colloidal silicon dioxide, D&C yellow no. 10 aluminum lake, magnesium stearate, microcrystalline cellulose

Questions?

1-800-382-7219Dramamine.com

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