MOTION-TIME CHEWABLE- meclizine hcl tablet, chewable 
NuCare Pharmaceuticals,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 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

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

When using this product

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

Other information

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.

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MOTION-TIME  CHEWABLE
meclizine hcl tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68071-4595(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:68071-4595-330 in 1 BOTTLE; Type 0: Not a Combination Product10/11/2018
2NDC:68071-4595-220 in 1 BOTTLE; Type 0: Not a Combination Product10/11/2018
3NDC:68071-4595-440 in 1 BOTTLE; Type 0: Not a Combination Product10/11/2018
4NDC:68071-4595-660 in 1 BOTTLE; Type 0: Not a Combination Product10/11/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33608/09/2010
Labeler - NuCare Pharmaceuticals,Inc. (010632300)
Establishment
NameAddressID/FEIBusiness Operations
NuCare Pharmaceuticals,Inc.010632300repack(68071-4595)

Revised: 2/2021
Document Id: bbf2197a-e8cc-b39e-e053-2a95a90ac082
Set id: 77f83f21-f880-6ac5-e053-2991aa0a8112
Version: 3
Effective Time: 20210222
 
NuCare Pharmaceuticals,Inc.