MECLIZINE HCL- meclizine hydrochloride tablets tablet

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 caplet)

Meclizine HCl 12.5 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

Adults & children 12 years and over: 2-4 caplets once daily

Children under 12 years: ask a doctor

HOW SUPPLIED

Other Information

each caplet contains: calcium 51 mg

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

Inactive ingredients

Microcrystalline cellulose, magnesium stearate, sodium starch glycolate, crospovidone, talc, and lactose.

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 - 12.5 mg Caplet Label

NDC: 13811-646-10

Meclizine HCl
12.5 mg

100 CAPLETS

TRIGEN
LABORATORIES

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

INGREDIENTS AND APPEARANCE

MECLIZINE HCL 
meclizine hydrochloride tablets tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13811-646(NDC: 57631-007)
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
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
POVIDONE K30 (UNII: U725QWY32X)
TALC (UNII: 7SEV7J4R1U)
LACTOSE (UNII: J2B2A4N98G)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	ET5
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13811-646-10	100 in 1 BOTTLE
2	NDC: 13811-646-01	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)