MECLIZINE- meclizine hcl 25mg tablet, chewable 
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 tablet)

Meclizine HCl 25mg

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 1 or 2 tablets once daily or as directed by doctor

Other information

Inactive ingredients

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

Questions?

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

NDC 66424-0387-01

*Compare to the active ingredient in Bonine®

MECLIZINE

CHEWABLE

Raspberry Flavor

Meclizine HCl 25mg

Anti-Emetic

• Motion Sickness • Nausea • Vomiting

100 TABLETS

SDA

LABORATORIES

SDA Meclizine 25 mg Tablet Package Label

MECLIZINE 
meclizine hcl 25mg tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66424-387
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
FlavorImprint Code PH051
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66424-387-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2018
2NDC:66424-387-101000 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(66424-387) , pack(66424-387) , analysis(66424-387)

Revised: 2/2018
Document Id: d15f315a-ad97-4ad3-a115-2ce1313229ad
Set id: 681bdc38-c688-4349-8b61-85dad18588d3
Version: 1
Effective Time: 20180201
 
SDA Laboratories, Inc.