MECLIZINE HCL- meclizine hcl tablet
Preferred Pharmaceuticals, 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

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

How Supplied

Bottle of 2 - 68788-0118-2

Bottle of 25 - 68788-0118-5

Bottle of 30 - 68788-0118-3

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 Preferred Pharmaceuticals, Inc.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Meclizine HCL

COMPARE TO ACTIVE INGREDIENT IN BONINE

Meclizine HCl 25 mg (ANTIEMETIC)

MECLIZINE HCL
meclizine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68788-0118(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:68788-0118-2	2 in 1 BOTTLE; Type 0: Not a Combination Product	12/13/2012	11/19/2020
2	NDC:68788-0118-5	25 in 1 BOTTLE; Type 0: Not a Combination Product	12/13/2012	11/19/2020
3	NDC:68788-0118-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	12/13/2012	11/19/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part336	12/13/2012	11/19/2020

Labeler - Preferred Pharmaceuticals, Inc. (791119022)

Registrant - Preferred Pharmaceuticals, Inc. (791119022)

Name	Address	ID/FEI	Business Operations
Establishment
Preferred Pharmaceuticals, Inc.		791119022	REPACK(68788-0118)

Revised: 11/2020

Document Id: 944453df-426d-43ce-9bc4-a465658fa2ad

Set id: dec9c5f6-929e-493d-ac4f-c24cf1f9e6ef

Version: 6

Effective Time: 20201119

Preferred Pharmaceuticals, Inc.