Rugby Tablet [Redpharm Drug, Inc.] -

RUGBY TABLET [REDPHARM DRUG, INC.]
PDF | XML

NDC	67296-1252-3
Set ID	4fa706cc-56e7-1ed0-e054-00144ff8d46c
Category	HUMAN OTC DRUG LABEL
Packager	RedPharm Drug, Inc.
Generic Name
Product Class	Antiemetic
Product Number
Application Number	PART336

View All Sections

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

INGREDIENTS AND APPEARANCE

RUGBY
rugby tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67296-1252(NDC:0536-1017)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570)	MECLIZINE HYDROCHLORIDE	12.5 mg

Ingredient Name	Strength
Inactive Ingredients
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
SODIUM SULFATE (UNII: 0YPR65R21J)

Product Characteristics
Color	white	Score	2 pieces
Shape	CAPSULE (modified capsule shaped uncoated tablet with bisect)	Size	3mm
Flavor		Imprint Code	19G
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:67296-1252-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	03/07/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part336	03/07/2014

Labeler - RedPharm Drug, Inc. (828374897)

Name	Address	ID/FEI	Business Operations
Establishment
RedPharm Drug Inc.		828374897	relabel(67296-1252) , repack(67296-1252)

View All Sections

Medic

RUGBY TABLET [REDPHARM DRUG, INC.]

Related Drugs