MECLIZINE HCl, USP 12.5 mg CAPLETS

Drug Details [pdf]

RUGBY MECLIZINE HCL, 12.5 MG EACH ANTIEMETIC- meclizine hcl tablet
RUGBY LABORATORIES

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.

----------

MECLIZINE HCl, USP 12.5 mg CAPLETS

Drug Facts

Active ingredient (in each caplet)

Meclizine HCl, USP 12.5 mg

Purpose

Antiemetic

Uses

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

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.

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

Other information

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

Inactive ingredients

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

Questions or comments?

call 1-800-645-2158

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

Distributed by: Rugby Laboratories

17177 N. Laurel Park Drive, Suite 233

Livonia, MI 48152

www.rugbylaboratories.com

Rugby®

NDC: 0536-1017-01

Meclizine HCl, USP

12.5 mg Each

ANTIEMETIC

100 CAPLETS

Rugby Meclizine 1017

RUGBY MECLIZINE HCL, 12.5 MG EACH ANTIEMETIC
meclizine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	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
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)

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: 0536-1017-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/07/2014	01/31/2020
2	NDC: 0536-1017-10	1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/07/2014	01/31/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part336	03/07/2014	01/31/2020

Labeler - RUGBY LABORATORIES (079246066)

Registrant - GEMINI PHARMACEUTICALS INC. (055942270)

Name	Address	ID/FEI	Business Operations
Establishment
GEMINI PHARMACEUTICALS INC.		055942270	manufacture(0536-1017)

Revised: 4/2018

Document Id: 6a8cc572-608d-6b4a-e053-2991aa0aaa42

Set id: efd5bdae-65a8-4e1c-8c39-f1c6a1a62ac0

Version: 4

Effective Time: 20180423

RUGBY LABORATORIES

MECLIZINE HCl, USP 12.5 mg CAPLETS

Rugby by

Drug Labeling and Warnings

Drug Details [pdf]

MECLIZINE HCl, USP 12.5 mg CAPLETS