MECLIZINE- meclizine hcl 12.5 mg tablet 
Pharbest Pharmaceuticals, Inc.

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Drug Facts

Active ingredient (in each caplet)

Meclizine HCl 12.5mg

Purpose

Antiemetic

Uses

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

Warnings

Do not use for 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

  • do not exceed recommended dosage
  • may cause drowsiness
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • use caution when driving a motor vehicle or operating machinery

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 (800-222-1222).

Directions

Adults and children 12 years and over

take 2 or 4 caplets once daily or as directed by 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 16103-386-08

Manufactured in the USA

Motion Sickness Relief

MECLIZINE

Meclizine HCl 12.5 mg

Anti-Emetic

• Motion Sickness • Nausea • Vomiting

100 CAPLETS

Meclizine 12.5 mg caplet Product Label

MECLIZINE 
meclizine hcl 12.5 mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16103-386
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
ColorwhiteScoreno score
ShapeCAPSULE (CAPSULE SHAPED TABLET) Size13mm
FlavorImprint Code PH049
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16103-386-08100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2018
2NDC:16103-386-111000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00902/01/2018
Labeler - Pharbest Pharmaceuticals, Inc. (557054835)
Registrant - Pharbest Pharmaceuticals, Inc. (557054835)
Establishment
NameAddressID/FEIBusiness Operations
Pharbest Pharmaceuticals, Inc.557054835manufacture(16103-386) , label(16103-386) , pack(16103-386) , analysis(16103-386)

Revised: 12/2025
Document Id: d7d81436-c338-4988-bf9e-a721e0cb8f91
Set id: 8b3c9283-b618-4d57-9f15-7cf73e8737f5
Version: 3
Effective Time: 20251224
 
Pharbest Pharmaceuticals, Inc.