MECLIZINE- meclizine hcl 12.5 mg tablet 
SDA Laboratories, Inc.

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.

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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 unless directed by a doctor if you have

Do not take if you are taking sedatives or tranquilizers, without first consulting your doctor.

When using this product

  • do not exceed recommended dosage
  • drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful 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.

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?

Adverse drug event call (800) 687-0176 (M - F, 8AM - 4PM EST).

NDC 66424-0386-10

MECLIZINE

Meclizine HCl 12.5mg

Anti-Emetic

• Motion Sickness • Nausea • Vomiting

1000 CAPLETS

SDA

LABORATORIES

SDA Meclizine 12.5 mg Caplet Package Label

MECLIZINE 
meclizine hcl 12.5 mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66424-386
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
Colorwhite (WHITE COLOR) Scoreno score
ShapeCAPSULE (CAPSULE SHAPED TABLET) Size13mm
FlavorImprint Code PH049
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66424-386-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2018
2NDC:66424-386-101000 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 finalpart33602/01/2018
Labeler - SDA Laboratories, Inc. (948067889)
Registrant - Pharbest Pharmaceuticals, Inc. (557054835)
Establishment
NameAddressID/FEIBusiness Operations
Pharbest Pharmaceuticals, Inc.557054835manufacture(66424-386) , pack(66424-386) , analysis(66424-386)

Revised: 2/2018
Document Id: 01ecb5d8-172e-4a82-8c7e-94e079aacbb1
Set id: f2581bc8-7845-4c65-b5cf-fbce48768fb9
Version: 1
Effective Time: 20180201
 
SDA Laboratories, Inc.