MECLIZINE HCL- meclizine hydrochloride tablet 
Rising Pharma Holdings, Inc.

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MECLIZINE HYDROCHLORIDE TABLETS, USP 12.5 mg

Drug Facts

Active ingredient (in each tablet)

Meclizine HCl, USP 12.5 mg

Purpose

Antiemetic

Uses

prevents and treats nausea, vomiting or dizziness associated with motion sickness.

Warnings

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

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

Do not take this product if you are

taking sedatives or tranquilizers, without first consulting your doctor.

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 a Poison Control Center right away (1-800-222-1222).

Directions

dosage should be taken one hour before travel starts

adults and children 12 years and overtake 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

Questions or comments?

Call 1-844-474-7464 Monday to Friday 8 AM - 5 PM ET

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

Mfg. Lic. No.: G/1430

Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816

Issued: 02/2024

138528

PRINCIPAL DISPLAY PANEL - 12.5 mg tablets container label

NDC 57237-333-01

Meclizine Hydrochloride Tablets, USP

12.5 mg

100 Tablets

meclizine-12.5mg-100ct

MECLIZINE HCL 
meclizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57237-333
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:57237-333-01100 in 1 BOTTLE; Type 0: Not a Combination Product07/22/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM009.5007/22/2024
Labeler - Rising Pharma Holdings, Inc. (116880195)
Registrant - Unique Pharmaceutical Laboratories (917165052)
Establishment
NameAddressID/FEIBusiness Operations
Unique Pharmaceutical Laboratories650434645manufacture(57237-333)

Revised: 11/2024
Document Id: f603203c-84a4-4b41-a244-cff913e5c2e0
Set id: acdf636c-66f1-4a1f-87a8-786f51d75708
Version: 3
Effective Time: 20241113
 
Rising Pharma Holdings, Inc.