MECLIZINE HCL- meclizine hydrochloride tablet 
Drug Ocean LLC

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MECLIZINE HYDROCHLORIDE TABLETS, 12.5 mg

DRUG FACTS

Active Ingredients (in each tablet)

Meclizine HCl, USP 12.5 mg

Purpose

Antiemetic

Uses:

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

Warnings:

Do not take this product, unless directed by a doctor, if you have

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

Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor

When using 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 a Poison Control Center right away

Directions

 adults and children 12 years and over   take 2 or 4 tablets once daily or as directed by a doctor

Other Information

Inactive ingredients

colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose

Call 1-844-200-6566 Monday to Friday 9 AM to 5 PM EST

TAMPER EVIDENT: DO NOT USE IF FOIL SEAL UNDER CAP, PRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING

Distributed by:
Drug Ocean LLC,
1 Bridge Plaza, North Central Road,

6th Floor, Suite 675,

Fort Lee, NJ 07024

Manufactured by:
Unique Pharmaceutical Laboratories
(A Div. of J. B. Chemicals & Pharmaceuticals Ltd.)
Mumbai 400 030, India

ORG 12/23

PRINCIPAL DISPLAY PANEL - 12.5 mg Tablet Label

NDC 70985-009-01

Meclizine HCl

12.5 mg

100 Tablets

Distributed by:

Drug Ocean LLC,

1 Bridge Plaza, North Central Road,

6th Floor, Suite 675
Fort Lee, NJ 07024

Manufactured by:
Unique Pharmaceutical Laboratories
(A Div. of J. B. Chemicals & Pharmaceuticals Ltd.)
Mumbai 400 030, India

ORG 12/23

12.5

MECLIZINE HCL 
meclizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70985-009
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE12.5 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSPOVIDONE (UNII: 2S7830E561)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
Product Characteristics
Colorwhite (White to Off White) Scoreno score
ShapeROUNDSize7mm
FlavorImprint Code AB;12
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70985-009-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/25/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00906/25/2021
Labeler - Drug Ocean LLC (080381835)
Registrant - Drug Ocean LLC (080381835)
Establishment
NameAddressID/FEIBusiness Operations
Unique Pharmaceutical Laboratories650434645manufacture(70985-009)

Revised: 12/2023
Document Id: 0d30d9d6-3740-259d-e063-6394a90a651e
Set id: e3b63436-fc27-4629-8d19-808e28d25110
Version: 2
Effective Time: 20231223
 
Drug Ocean LLC