RUGBY MECLIZINE HCL- meclizine hydrochloride tablet, film coated

Rugby Meclizine HCl by

Drug Labeling and Warnings

Rugby Meclizine HCl by is a Otc medication manufactured, distributed, or labeled by RUGBY LABORATORIES. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 a 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, hypromellose, magnesium stearate, microcrystalline cellulose, propylene glycol, silicon dioxide, sodium sulfate, stearic acid, titanium dioxide.

QUESTIONS

Questions or comments?

Call1-800-645-2158

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

PRINCIPAL DISPLAY PANEL

Rugby®

NDC: 0536-1178-01

NEW FORMULA AND APPEARANCE

Meclizine HCl, USP

12.5 mg Each

ANTIEMETIC

100 CAPLETS

INGREDIENTS AND APPEARANCE

RUGBY MECLIZINE HCL 
meclizine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1178
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM SULFATE (UNII: 0YPR65R21J)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white (Film Coated)	Score	2 pieces
Shape	CAPSULE (Modified)	Size	13mm
Flavor		Imprint Code	19G
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1178-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/20/2018
2	NDC: 0536-1178-10	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/20/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part336	04/20/2018

Labeler - RUGBY LABORATORIES (079246066)