Rugby Travel Sickness
FDA Label NDC 12634-246

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Apotheca Inc. for the product Rugby Travel Sickness (NDC 12634-246). 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 chewable tablet), purpose, uses, otc - do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, when using this product, otc - pregnancy 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 Chewable Tablet)

Meclizine HCl USP 25 mg


Purpose

Antiemetic


Uses

  • prevents and treats nausea, vomiting or dizziness due to motion sickness

Otc - Do Not Use

Do not use in children under 12 years of age unless directed by a doctor


Ask A Doctor Before Use If You Have

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use it you are taking sedatives or tranquilizers.


When Using This Product

  • may cause drowsiness
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • 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.


Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact the poison control center immediately.


Directions

Dosage should be taken one hour before travel starts

Adults and children 12 years of age and older:

Chew 1-2 tablets once daily, or as directed by a doctor

Children under 12 years: do not give this product to children under 12 years of age unless directed by a doctor


Other Information


  • Phenylketonurics: Contains Phenylalanine 0.28 mg per tablet
  • store at room temperature

Inactive Ingredients

aspartame,croscarmellose sodium, dextrose, FD and C Red #40 Lake, magnesium stearate, maltodextrin, microcrystalline cellulose, natural and artificial flavors, silicon dioxide, sodium sulfate, sugar, tricalcium phosphate.


Questions Or Comments?

1-800-645-2158


Other Safety Information

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

* Please review the disclaimer below.