MECLIZINE HCL- meclizine hydrochloride tablet 
BluePoint Laboratories

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 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

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

PRINCIPAL DISPLAY PANEL - 12.5 mg Tablet Label

NDC 68001-528-00

Meclizine Hydrochloride Tablets, USP

12.5 mg

100 Tablets

label

MECLIZINE HCL 
meclizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68001-528
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:68001-528-00100 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33603/14/2022
Labeler - BluePoint Laboratories (985523874)
Registrant - Unique Pharmaceutical Laboratories (917165052)
Establishment
NameAddressID/FEIBusiness Operations
Unique Pharmaceutical Laboratories650434645manufacture(68001-528)

Revised: 3/2022
Document Id: d9ca5450-5e5b-af28-e053-2995a90a79f6
Set id: d9cae5a6-8d4b-bdaf-e053-2995a90a7d44
Version: 1
Effective Time: 20220309
 
BluePoint Laboratories