MECLIZINE HCL 25 MG- meclizine hydrochloride tablet, chewable 
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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Meclizine HCl 25 mg Chewable Tablets

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

Drug Facts

Active ingredient (in each chewable tablet)

Meclizine HCl, USP 25 mg

Purpose

Antiemetic

Uses

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

Warnings

Do not use in children under 12 years of age unless directed by a doctor.

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

may cause drowsiness
alcohol, sedatives and tranquilizers may increase drowsiness
avoid alcoholic drinks
use caution 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 the poison control center immediately.

Directions

dosage should be taken one hour before travel starts.
adults and children 12 years of age and older: Chew 1-2 tablets once daily or as directed by a doctor
children under 12 years: do not give this product to children under 12 years of age unless directed by a doctor

Other information

phenylketonurics: contains phenylalanine 0.28 mg per tablet
store at room temperature in a dry place

Inactive ingredients Aspartame, croscarmellose sodium, dextrose, FD&C red #40 lake, magnesium stearate, maltodextrin, microcrystalline cellulose, natural and artificial flavors, silicon dioxide, sodium sulfate, sugar, tricalcium phosphate.

Questions? If you have any questions or comments or to report an adverse event, please contact (800) 795-9775.

Distributed by: Plus Pharma, Commack, NY 11725

*Plus Pharma is not affiliated with the owner of the registered trademark Bonine®.

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

Plus Pharma™

Repackaged By: Preferred Pharmaceuticals Inc.

NDC 68788-7850

MECLIZINE HCl 25 mg

ANTIEMETIC

Treats and Prevents Motion Sickness

Prevents nausea, dizziness and vomiting

*Compare to the Active Ingredient in Bonine®

Raspberry

Natural & Artificial Flavor

Contains no ingredient from a gluten-containing grain (wheat, barley, or rye).

CHEWABLE TABLETS • 25 mg each

Meclizine HCL 25mg Chewable Tablets
MECLIZINE HCL 25 MG 
meclizine hydrochloride tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-7850(NDC:51645-994)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME (UNII: Z0H242BBR1)  
SUCROSE (UNII: C151H8M554)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM SULFATE (UNII: 0YPR65R21J)  
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
Product Characteristics
Colorpink (Uncoated) Score2 pieces
ShapeROUND (Biconvex) Size8mm
FlavorRASPBERRYImprint Code 21G
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68788-7850-110 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/26/2021
2NDC:68788-7850-330 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/26/2021
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33601/26/2021
Labeler - Preferred Pharmaceuticals Inc. (791119022)
Registrant - Preferred Pharmaceuticals Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals Inc.791119022REPACK(68788-7850)

Revised: 1/2021
Document Id: 055cf3a2-aad2-4265-96de-1dd23163aa1b
Set id: 055cf3a2-aad2-4265-96de-1dd23163aa1b
Version: 1
Effective Time: 20210126
 
Preferred Pharmaceuticals Inc.