MECLIZINE- meclizine hcl 12.5mg tablet 
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 caplet)

Meclizine HCl 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 caplets once daily or as directed by a doctor 

Other information

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

Questions or comments?

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

PHARBEST

NDC 73057-386-11

Manufactured in the USA

Motion Sickness Relief

MECLIZINE

Meclizine HCl 12.5 mg

Antiemetic

• Motion Sickness • Nausea • Vomiting

1000 CAPLETS

Ulai Meclizine 12.5 mg Caplet 1000 ct. Label

MECLIZINE 
meclizine hcl 12.5mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73057-386
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeCAPSULE (Capsule shaped tablet) Size13mm
FlavorImprint Code PH049
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73057-386-111000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2019
2NDC:73057-386-08100 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)

Revised: 1/2022
Document Id: d6e7750a-1bab-ba9b-e053-2a95a90acc4b
Set id: d304e205-85fa-494a-9a68-ae6855b139b1
Version: 2
Effective Time: 20220131
 
Ulai Health LLC