Meclizine HCl by Aidarex Pharmaceuticals LLC MECLIZINE HCL tablet

Meclizine HCl by

Drug Labeling and Warnings

Meclizine HCl by is a Otc medication manufactured, distributed, or labeled by Aidarex Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

(in each tablet)

Meclizine HCl 25 mg 

Purpose

Antiemetic

Uses

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

WARNINGS

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

• you may get drowsy
• avoid alcoholic drinks
• alcohol, sedatives & tranquilizers may increase drowsiness
• be careful 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 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

Other Information

• phenylketonurics: each tablet contains: phenylalanine 0.28mg
• store at room temperature 15°-30°C (59°-86°F)

Inactive Ingredients

aspartame, compressible sugar, croscarmellose sodium, dextrose, FD&C red # 40(Al-lake), magnesium stearate, microcrystalline cellulose, raspberry flavor

Questions or Comments

Call 1-800-645-2158, 9 am – 5 pm ET, Monday - Friday

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

Rugby® Duluth, Georgia 30097

Repackaged By :
Aidarex Pharmaceuticals LLC,
Corona, CA 92880

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Meclizine HCl

COMPARE TO ACTIVE INGREDIENT IN BONINE

Meclizine HCl 25 mg (ANTIEMETIC)

NDC: 33261-0413-30

30 CHEWABLE TABLETS

Contains Aspartame

Rugby

Duluth, Georgia 30097

Repackaged By :
Aidarex Pharmaceuticals LLC,
Corona, CA 92880

INGREDIENTS AND APPEARANCE

MECLIZINE HCL 
meclizine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 33261-413(NDC: 0536-3990)
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ASPARTAME (UNII: Z0H242BBR1)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SUCROSE (UNII: C151H8M554)
DEXTROSE (UNII: IY9XDZ35W2)
FD&C RED NO. 40 (UNII: WZB9127XOA)
RASPBERRY (UNII: 4N14V5R27W)

Product Characteristics
Color	RED	Score	2 pieces
Shape	ROUND	Size	8mm
Flavor	RASPBERRY	Imprint Code	AP;115
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 33261-413-30	30 in 1 BOTTLE, PLASTIC
2	NDC: 33261-413-60	60 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part336	07/22/2008

Labeler - Aidarex Pharmaceuticals LLC (801503249)