MECLIZINE- meclizine hcl tablet
Contract Pharmacal Corp.

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.

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2691

Drug Facts

Active ingredient

(in each tablet)

Meclizine HCl 25 mg

Purpose

Antiemetic

Uses

for the prevention and treatment of the nausea, vomiting, dizziness associated with 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

breathing problems such as emphysema or chronic bronchitis
glaucoma
difficulty in urination due to enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

drowsiness may occur
avoid alcoholic beverages
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery

If pregnant or breast-feeding,

ask a health care professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

To prevent motion sickness, the first dose should be taken one hour before starting activity.
Adults and children 12 years of age and over: take 1 to 2 tablets once daily, or as directed by a doctor. Do not exceed 2 tablets in 24 hours. Not for frequent or prolonged use except on the advice of a doctor.

DO NOT EXCEED RECOMMENDED DOSE

Other information

Store at room temperature, USP

Inactive ingredient

Corn Starch, Croscarmellose Sodium, D&C Yellow #10 Lake, Lactose, Magnesium Stearate, Microcrystalline Cellulose, Silica and Stearic Acid.

R02/11

Manufactured by:
Contract Pharmacal Corp.
135 Adams Avenue
Hauppauge, NY 11788 USA
www.cpc.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

165bf665-figure-01

MECLIZINE
meclizine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10267-2691
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570)	MECLIZINE HYDROCHLORIDE	25 mg

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	yellow (Pale yellow)	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	CPC;2691
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10267-2691-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	07/24/2001	05/31/2015
2	NDC:10267-2691-4	1000 in 1 BOTTLE; Type 0: Not a Combination Product	07/24/2001	05/31/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part336	07/24/2001	05/31/2015

Labeler - Contract Pharmacal Corp. (057795122)

Registrant - Contract Pharmacal Corp. (057795122)

Name	Address	ID/FEI	Business Operations
Establishment
Contract Pharmacal Corp		968334974	manufacture(10267-2691)

Revised: 10/2017

Document Id: 5be8768a-f4a1-36bc-e053-2991aa0a3ddc

Set id: 6d592399-3930-4d59-bdce-b6fa8ad21358

Version: 2

Effective Time: 20171019

Contract Pharmacal Corp.