MOTION-TIME CHEWABLE- meclizine hcl tablet, chewable 
RedPharm Drug, 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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MECLIZINE 25MG

Active ingredient (in each tablet)

Meclizine HCl 25 mg

Purpose

Antiemetic

Uses

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

Warnings

Do not give to children under 12 years of age unless directed by a doctor

Do not take unless directed by a doctor if you have

  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis

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
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • 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

  • dosage should be taken one hour before travel starts
  • adults and children 12 years of age and over: take 1 to 2 tablets once daily or as directed by a doctor

Other information

  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F) in a dry place
  • use by expiration date on package

Inactive ingredients

anhydrous lactose, colloidal silicon dioxide, crospovidone, dextrose, FD-C red 40 aluminum lake, magnesium stearate, microcrystalline cellulose, modified corn starch, propylene glycol, raspberry flavor, silicon dioxide, sodium saccharin, stearic acid, talc, vanilla flavor

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABEL

MOTION-TIME  CHEWABLE
meclizine hcl tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67296-1626(NDC:49483-333)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE25 mg  in 25 
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
CROSPOVIDONE (UNII: 68401960MK)  
DEXTROSE (UNII: IY9XDZ35W2)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
RASPBERRY (UNII: 4N14V5R27W)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
VANILLA (UNII: Q74T35078H)  
Product Characteristics
ColorpinkScore2 pieces
ShapeROUNDSize9mm
FlavorRASPBERRYImprint Code TCL333
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67296-1626-330 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33601/01/2019
Labeler - RedPharm Drug, Inc. (828374897)
Establishment
NameAddressID/FEIBusiness Operations
RedPharm Drug, Inc.828374897repack(67296-1626) , relabel(67296-1626)

Revised: 1/2021
Document Id: b8d0902d-38fc-44a0-e053-2995a90a5c32
Set id: 888c83ef-5392-662b-e053-2a95a90a9682
Version: 2
Effective Time: 20210113
 
RedPharm Drug, Inc.