Motion Sickness Relief Tablet, Film Coated
FDA Label NDC 83059-0007

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Shield Pharmaceuticals Corp for the product Motion Sickness Relief (NDC 83059-0007). 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 liquid-filled capsule), purpose, uses, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, 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

Shield Pharmaceuticals Corp.
Carle Place, NY 11514

Active Ingredient (In Each Liquid-Filled Capsule)

Meclizine HCl 25 mg

Purpose

Antiemetic

Uses

for the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness

Warnings

Do not usefor children under 12 years of age unless directed by a doctor.

Ask A Doctor Before Use If You Have

  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.

When Using This Product

  • drowsiness may occur n avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.1(800)222-1222

Directions

  • do not take more than directed
  • take first dose ½ 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

  • TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) protect from heat and humidity

Inactive Ingredients

colloidal silicon dioxide, D&C yellow #10 aluminum lake, lactose monohydrate, magnesium stearate, pregelatinized starch.

Questions Or Comments?

1-800-373-6981 (toll-free)

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Compare to Dramamine® Less Drowsy active ingredient†

LESS DROWSY FORMULA

Motion Sickness Relief

Meclizine HCl, 25 mg

Antiemetic
Helps prevent nausea and dizziness due to motion sickness

For Ages 12 and Over

* Please review the disclaimer below.