MECLIZINE HCL- meclizine hydrochloride tablet 
Drug Ocean LLC

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 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,
221 River Street, Suite 9051,
Hoboken, NJ 07030

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

ORG 05/21

PRINCIPAL DISPLAY PANEL - 12.5 mg Tablet Label

NDC 70985-009-01

Meclizine HCl
12.5 mg

100 Tablets

Distributed by:
Drug Ocean LLC,
221 River Street, Suite 9051,
Hoboken, NJ 07030

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

ORG 05/21

PRINCIPAL DISPLAY PANEL - 12.5 mg - 100 caplets

PRINCIPAL DISPLAY PANEL - 12.5 mg - 100 caplets

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 finalpart33606/25/2021
Labeler - Drug Ocean LLC (080381835)
Registrant - Drug Ocean LLC (080381835)
Establishment
NameAddressID/FEIBusiness Operations
Unique Pharmaceutical Laboratories650434645manufacture(70985-009)

Revised: 6/2021
Document Id: c5d624a6-6f88-727e-e053-2a95a90a4655
Set id: e3b63436-fc27-4629-8d19-808e28d25110
Version: 1
Effective Time: 20210628
 
Drug Ocean LLC