MECLIZINE HCL- meclizine hcl tablet
REMEDYREPACK 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.

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Travel Sickness

OTC - ACTIVE INGREDIENT

(in each tablet)

Meclizine HCl 25 mg

OTC - PURPOSE

Antiemetic

INDICATIONS & USAGE

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.

DOSAGE & ADMINISTRATION

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

OTC - KEEP OUT OF REACH OF CHILDREN

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

INACTIVE INGREDIENT

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

OTC - QUESTIONS

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 SECTION

DRUG: Meclizine HCl

GENERIC: Meclizine HCl

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 52125-921-10

ACTIVE INGREDIENT(S):

MECLIZINE HYDROCHLORIDE 25mg in 1

INACTIVE INGREDIENT(S):

CELLULOSE, MICROCRYSTALLINE
DEXTROSE
FD&C RED NO. 40
SUCROSE
ASPARTAME
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
RASPBERRY

COLOR: red

FLAVOR: RASPBERRY

SHAPE: ROUND

SCORE: Two even pieces

SIZE: 8 mm

IMPRINT: AP;115

PACKAGING: 6 in 1 BOTTLE

MM1

MM2

MECLIZINE HCL
meclizine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52125-921(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
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
DEXTROSE (UNII: IY9XDZ35W2)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SUCROSE (UNII: C151H8M554)
ASPARTAME (UNII: Z0H242BBR1)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
RASPBERRY (UNII: 4N14V5R27W)

Product Characteristics
Color	red	Score	2 pieces
Shape	ROUND (TABLET)	Size	8mm
Flavor	RASPBERRY	Imprint Code	AP;115
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52125-921-10	6 in 1 BOTTLE; Type 0: Not a Combination Product	09/18/2014	09/18/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part336	09/18/2014	09/18/2015

Labeler - REMEDYREPACK INC. (829572556)

Revised: 12/2016

Document Id: 43bb47f4-a78e-2704-e054-00144ff8d46c

Set id: 6eb5ad34-42b0-4f23-849c-ef23145cd7d3

Version: 2

Effective Time: 20161215

REMEDYREPACK INC.