MECLIZINE HCL 25 MG- meclizine hydrochloride tablet, chewable 
Gemini Pharmaceuticals, Inc. dba Plus Pharma

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.

----------

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

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product

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

Other information

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®.

NDC 51645-994-01

Plus Pharma™

MECLIZINE HCl 25 mg

ANTIEMETIC

Treats and Prevents Motion Sickness

*Compare to the Active Ingredient in Bonine®

Prevents nausea, dizziness and vomiting

Raspberry

Natural & Artificial Flavor

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

100 CHEWABLE TABLETS • 25 mg each

51645-994-01

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

Plus Pharma™

NDC 51645-994-10

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).

1000 CHEWABLE TABLETS • 25 mg each

51645-994-10

MECLIZINE HCL 25 MG 
meclizine hydrochloride tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)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 (UNII: IY9XDZ35W2)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (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:51645-994-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/15/2015
2NDC:51645-994-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/15/2015
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33610/15/2015
Labeler - Gemini Pharmaceuticals, Inc. dba Plus Pharma (055942270)
Establishment
NameAddressID/FEIBusiness Operations
Gemini Pharmaceuticals, Inc.055942270manufacture(51645-994)

Revised: 11/2020
Document Id: b3dc2b97-9b7b-1ced-e053-2a95a90a403c
Set id: 18a59c8a-6d8a-2ad0-e054-00144ff88e88
Version: 3
Effective Time: 20201111
 
Gemini Pharmaceuticals, Inc. dba Plus Pharma