MECLIZINE- meclizine hcl 25mg tablet, chewable 
Ulai Health 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.

----------

Drug Facts

Active ingredient (in each tablet)

Meclizine HCl 25mg

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 1 or 2 tablets once daily or as directed by a doctor 

Other information

Inactive ingredients

croscarmellose sodium, dextrose, FD&C Red#40, raspberry flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium saccharine, stearic acid

Questions or comments?

(866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)

PHARBEST

NDC 73057-387-11

Manufactured in the USA

Chewable, Once-A-Day Protection

*Compare to the active ingredient in Bonine®

MECLIZINE

CHEWABLE

Raspberry Flavor

Meclizine HCl 25mg

Antiemetic

• Motion Sickness • Nausea • Vomiting

1000 TABLETS

Ulai Meclizine 25 mg tablet 1000 ct. Label

MECLIZINE 
meclizine hcl 25mg tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73057-387
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
DEXTROSE (UNII: IY9XDZ35W2)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
Colorpink (LIGHT PINK COLOR) Score2 pieces
ShapeROUND (Round Tablet) Size8mm
FlavorRASPBERRYImprint Code PH051
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73057-387-111000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2019
2NDC:73057-387-08100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33607/08/2019
Labeler - Ulai Health LLC (081181535)
Registrant - Pharbest Pharmaceuticals, Inc. (557054835)
Establishment
NameAddressID/FEIBusiness Operations
Pharbest Pharmaceuticals, Inc.557054835manufacture(73057-387) , analysis(73057-387) , pack(73057-387) , label(73057-387)

Revised: 7/2019
Document Id: 3c884e11-5f9b-4a8a-9a2b-179a19b20244
Set id: ea2e6834-c11a-40f8-887c-e02419023e7b
Version: 1
Effective Time: 20190722
 
Ulai Health LLC