Motion Sickness Relief Tablet, Chewable
FDA Label NDC 51013-322

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Puracap Pharmaceutical Llc for the product Motion Sickness Relief (NDC 51013-322). 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 (in each tablet), purpose, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, 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 Hydrochloride 25 mg

Purpose

Antiemetic

Uses

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

  • nausea
  • vomiting
  • dizziness

Do Not Use

for 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 one 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

  • Phenylketonurics: each tablet contains: phenylalanine 0.28 mg
  • store at room temperature 15° - 30°C (59° - 86°F)

Inactive Ingredients

Aspartame, compressible sugar, croscarmellose sodium, dextrose, FD&C red 40 (al-lake), magnesium stearate, microcrystalline cellulose, raspberry flavor

Questions Or Comments?

Call toll free: 1-855-215-8180

Principal Display Panel

Motion Sickness Relief

30 Tablets   15 Pouches (2 Tablets per Pouch)

NDC 51013-322-54

Cvsf36-00 (Cvsf36 00)

Cvsf36-00 (Cvsf36 00)

Cvsb36-00 (Cvsb36 00)

Cvsb36-00 (Cvsb36 00)

* Please review the disclaimer below.