TRAVEL TIME- meclizine hcl tablet, chewable 
Provision Medical Products

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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Uses: For the prevention and treatment of nausea, vomiting and dizziness associated with motion sickness.

If you are pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN.

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 a 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

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.

Inactive ingredients:Anhydrous lactose, colloidal silicon dioxide, crospovidone, dextrose, FDC red 40 aluminum lake, magnesium stearate,microcrystalline cellulose, modi¬fied corn starch, propylene glycol, raspberry flavor, silicon dioxide, sodium saccharin, stearic acid, talc, vanilla flavor

MECLIZINE HYDROCHLORIDE 25 MG

Antiemetic

TRAVEL TIME BOX
TRAVEL TIME 
meclizine hcl tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69103-2170
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
STARCH, CORN (UNII: O8232NY3SJ)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
LACTOSE (UNII: J2B2A4N98G)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSPOVIDONE (UNII: 2S7830E561)  
DEXTROSE (UNII: IY9XDZ35W2)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
Colorpink (ROSE PINK) Score2 pieces
ShapeROUNDSize8mm
FlavorImprint Code TCL333
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69103-2170-01000 in 1 PACKAGE04/08/201510/02/2017
12 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33604/03/201510/02/2017
Labeler - Provision Medical Products (036936831)
Registrant - Provision Medical Products (036936831)
Establishment
NameAddressID/FEIBusiness Operations
Ultraseal Corporation085752004pack(69103-2170)
Establishment
NameAddressID/FEIBusiness Operations
ULTRAtab Laboratories, Inc.151051757manufacture(69103-2170)

Revised: 11/2017
 
Provision Medical Products