Meclizine Hcl Tablet [Rugby Laboratories Inc.] -

MECLIZINE HCL TABLET [RUGBY LABORATORIES INC.]
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NDC	0536-3990-01, 0536-3990-10
Set ID	cf9b880e-e8df-4419-aae5-1bc39f3296e0
Category	HUMAN OTC DRUG LABEL
Packager	Rugby Laboratories Inc.
Generic Name
Product Class	Antiemetic
Product Number
Application Number	PART336

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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
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Meclizine HCl

$C:\Users\advance\Desktop\word docs - rugby\Meclizine 25 mg 100-1000 ct\Figure 3.png$

COMPARE TO ACTIVE INGREDIENT IN BONINE

Meclizine HCl 25 mg (ANTIEMETIC)

NDC 0536-3990-10

1000 CHEWABLE TABLETS

Contains Aspartame

Rugby

Duluth, Georgia 30097

$C:\Users\advance\Desktop\word docs - rugby\Meclizine 25 mg 100-1000 ct\Figure-1.png$

$C:\Users\advance\Desktop\word docs - rugby\Meclizine 25 mg 100-1000 ct\Figure-2.png$

COMPARE TO ACTIVE INGREDIENT IN BONINE

Meclizine HCl 25 mg (ANTIEMETIC)

NDC 0536-3990-01

100 CHEWABLE TABLETS

Contains Aspartame

Rugby

Duluth, Georgia 30097

INGREDIENTS AND APPEARANCE

MECLIZINE HCL
meclizine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0536-3990
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
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

#	Item Code	Package Description
Packaging
1	NDC:0536-3990-10	1000 in 1 BOTTLE
2	NDC:0536-3990-01	100 in 1 BOTTLE

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

Labeler - Rugby Laboratories Inc. (191427277)

Registrant - Advance Pharmaceutical Inc. (078301063)

Name	Address	ID/FEI	Business Operations
Establishment
Advance Pharmaceutical Inc.		078301063	MANUFACTURE(0536-3990)

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Medic

MECLIZINE HCL TABLET [RUGBY LABORATORIES INC.]

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