MECLIZINE 25- meclizine hydrochloride tablet

Meclizine 25 by

Drug Labeling and Warnings

Meclizine 25 by is a Otc medication manufactured, distributed, or labeled by The Generic Pharmaceutical Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active Ingredients (in each immediate-release tablet)

Meclizine 25 mg

Purpose

Antiemetic

Indications and Usage

• For prevention and treatment of these symptoms associated with motion sickness:
  • nausea
  • vomiting
  • dizziness

Warnings

• Do not use for children under 12 years of age unless directed by a doctor.

Ask a doctor before use if you have

• glaucoma
• difficulty in urination due to enlargement of the prostate gland
• a breathing problem such as emphysema or chronic bronchitis

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

When using this product

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

If pregnant or breast-feeding,

• ask health professional before use.

Keep out of reach of children.

In case of accidental overdose, seek medical help or contact a Poison Control Center immediately. 1-800-222-1222

Directions

Do not exceed recommended dosage.

To prevent motion sickness; take the first dose one hour before starting activity.

• Adults and children 12 years of age and over: 1 to 2 tablets once daily, or as directed by a doctor.

Inactive ingredients

Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate

Questions and comments?

Call 1-205-313-8298

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Manufactured for
The Generic Pharmaceutical Company, Inc.
Leeds, AL 35094

PRINCIPAL DISPLAY PANEL - 25 mg Tablet Bottle Label

NDC: 57963-101-01
100 Tablets

Meclizine 25
Antiemetic

Each immediate-release tablet contains:
Meclizine HCl
25 mg

Store at 59°-86°F (15°-30°C)
[see USP Controlled Room Temperature].
Tamper evident by foil seal under cap.
Do not use if foil seal is broken or missing.

Manufactured for
The Generic Pharmaceutical Company, Inc.
Leeds, AL 35094

INGREDIENTS AND APPEARANCE

MECLIZINE 25 
meclizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57963-101
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
Magnesium Stearate (UNII: 70097M6I30)
Microcrystalline Cellulose (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	MC
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57963-101-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part336	12/01/2016

Labeler - The Generic Pharmaceutical Company (078787060)