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

meclizine chew 25mg
(click image for full-size original)

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.

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.