Meclizine HCl by Rugby Laboratories Inc. / Advance Pharmaceutical Inc. Travel Sickness

Drug Details [pdf]

MECLIZINE HCL- meclizine hcl tablet
Rugby Laboratories Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Travel Sickness

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

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)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SUCROSE (UNII: C151H8M554)
DEXTROSE, UNSPECIFIED FORM (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	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 0536-3990-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	07/22/2008	03/31/2018
2	NDC: 0536-3990-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	07/22/2008	07/29/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part336	07/22/2008	07/29/2018

Labeler - Rugby Laboratories Inc. (079246066)

Revised: 12/2019

Document Id: 49f7cd3c-50b8-480b-8167-7c605dbe53e2

Set id: cf9b880e-e8df-4419-aae5-1bc39f3296e0

Version: 3

Effective Time: 20191220

Rugby Laboratories Inc.