MECLIZINE HCL- meclizine hydrochloride chewable tablets tablet, chewable

Meclizine HCl by

Drug Labeling and Warnings

Meclizine HCl by is a Otc medication manufactured, distributed, or labeled by Trigen Laboratories, Inc., Trigen Laboratories, Inc... Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients (in each tablet)

Meclizine HCl 25 mg

Purpose

Antiemetic

Uses:

prevents and treats nausea, vomiting, or dizziness due to motion sickness. For other uses, consult your doctor.

WARNING: 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.

KEEP OUT OF REACH OF CHILDREN

ASK DOCTOR/PHARMACIST

Ask doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using product

You may get drowsy Avoid alcoholic drinks Alcohol, sedatives and tranquilizers may increase drowsiness Be careful when driving a motor vehicle or operating machinery

PREGNANCY OR BREAST FEEDING

If pregnant or breast feeding, ask a Physician before use.

Keep out of reach of children.

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

Directions

Take dose one hour before travel starts Tablets can be chewed or swallowed whole with water Adults & children 12 years and over: 1-2 tablets once daily Children under 12 years: ask a doctor

HOW SUPPLIED

Other Information

each tablet contains: calcium 51 mg

Store at room temperature 15°-30°C (59°-86°F)

Inactive ingredients

Microcrystalline cellulose, magnesium stearate, lactose, Raspberry flavor, FD&C Red #40 lake, starch, sodium saccharin, and dextrates hydrated.

SPL UNCLASSIFIED SECTION

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

TRIGEN
LABORATORIES

Manufactured for:
TRIGEN Laboratories, Inc., Sayreville, NJ 08872
www.trigenlab.com
Rev. 08/13

PRINCIPAL DISPLAY PANEL - 25 mg Chewable Tablet Label

NDC: 13811-648-10

Meclizine HCl
25 mg

100 CHEWABLE TABLETS

TRIGEN
LABORATORIES

INGREDIENTS AND APPEARANCE

MECLIZINE HCL 
meclizine hydrochloride chewable tablets tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13811-648(NDC: 57631-009)
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
LACTOSE (UNII: J2B2A4N98G)
FD&C RED NO. 40 (UNII: WZB9127XOA)
STARCH, CORN (UNII: O8232NY3SJ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
DEXTRATES (UNII: G263MI44RU)

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND	Size	8mm
Flavor	RASPBERRY	Imprint Code	ET1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13811-648-10	100 in 1 BOTTLE
2	NDC: 13811-648-01	1000 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part336	09/23/2013

Labeler - Trigen Laboratories, Inc. (830479668)

Registrant - Trigen Laboratories, Inc.. (830479668)