Rugby Travel Sickness: Package Insert and Label Information

RUGBY TRAVEL SICKNESS- meclizine hydrochloride tablet, chewable
RedPharm Drug, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each chewable tablet)

Meclizine HCl USP 25 mg

PURPOSE

Purpose

Antiemetic

INDICATIONS & USAGE

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

WARNINGS

Warnings

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

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

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.

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING

Other information

Phenylketonurics: Contains Phenylalanine 0.28 mg per tablet
Store at room temperature in a dry place
Keep lid tightly closed

INACTIVE INGREDIENT

nactive ingredients

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

QUESTIONS

Questions or comments?

call 1-800-645-2158

OTHER SAFETY INFORMATION

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

SPL UNCLASSIFIED SECTION

Distributed by: Rugby Laboratories

17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152

Keep out of reach of children.

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

PRINCIPAL DISPLAY PANEL

RUGBY TRAVEL SICKNESS rugby travel sickness tablet, chewable

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67296-1128(NDC:0536-1018) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MECLIZINE HYDROCHLORIDE (MECLIZINE) MECLIZINE HYDROCHLORIDE 25 mg

Inactive Ingredients Ingredient Name Strength ASPARTAME CROSCARMELLOSE SODIUM DEXTROSE FD&C RED NO. 40 MAGNESIUM STEARATE MALTODEXTRIN SODIUM SULFATE SUCROSE TRICALCIUM PHOSPHATE CELLULOSE, MICROCRYSTALLINE SILICON DIOXIDE

Product Characteristics Color pink Score 2 pieces Shape ROUND (Biconvex Uncoated Tablet with Bisect) Size 8mm Flavor Imprint Code 21G Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:67296-1128-3 30 TABLET, CHEWABLE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part336 08/19/2014

Labeler — RedPharm Drug, Inc. (828374897)

Establishment
Name	Address	ID/FEI	Operations
RedPharm Drug, Inc.		828374897	repack (67296-1128), relabel (67296-1128)

Revised: 01/2020 RedPharm Drug, Inc.