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Rugby by RedPharm Drug, Inc.

Medically reviewed on March 7, 2018

Dosage form: tablet
Ingredients: MECLIZINE HYDROCHLORIDE 12.5mg
Labeler: RedPharm Drug, Inc.
NDC Code: 67296-1252

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.

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each caplet)

Meclizine HCl, USP 12.5 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 if 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: take 2-4 caplets 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

Each Caplet Contains: Calcium 25 mg
store at room temperature in a dry place
Keep lid tightly closed

INACTIVE INGREDIENT

Inactive ingredients

croscarmellose sodium, dicalcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium sulfate, stearic acid.

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

www.rugbylaboratories.com

OTC KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF THE REACH OF CHILDREN

PRINCIPAL DISPLAY PANEL

RUGBY 
rugby tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67296-1252(NDC:0536-1017)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MECLIZINE HYDROCHLORIDE (MECLIZINE) MECLIZINE HYDROCHLORIDE12.5 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SILICON DIOXIDE 
STEARIC ACID 
CROSCARMELLOSE SODIUM 
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE 
SODIUM SULFATE 
Product Characteristics
ColorwhiteScore2 pieces
ShapeCAPSULE (modified capsule shaped uncoated tablet with bisect) Size3mm
FlavorImprint Code19G
Contains    
Packaging
#Item CodePackage Description
1NDC:67296-1252-330 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33603/07/2014
Labeler - RedPharm Drug, Inc. (828374897)
Establishment
NameAddressID/FEIOperations
RedPharm Drug Inc.828374897relabel(67296-1252), repack(67296-1252)

 
RedPharm Drug, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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