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Motion Sickness II by TOP CARE (Topco Associates LLC)

Medically reviewed on June 26, 2017

Dosage form: tablet
Ingredients: MECLIZINE HYDROCHLORIDE 25 mg
Labeler: TOP CARE (Topco Associates LLC)
NDC Code: 36800-620

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.

Drug Facts

Active ingredient (in each tablet)

Meclizine HCl 25 mg

Purpose

Antiemetic

Uses

for prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness.

Warnings

Do not use

for children under 12 years of age unless directed by a doctor.

Ask a doctor before use if you have
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to an enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product
  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution 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
  • to prevent motion sickness, the first dose should be taken 1 hour before starting activity
  • adults and children 12 years and over: 1 to 2 tablets once daily, or as directed by a doctor
  • do not exceed 2 tablets in 24 hours

Other information
  • store at room temperature 20º-25ºC (68º-77ºF)

Inactive ingredients

anhydrous lactose, colloidal silicon dioxide, corn starch, D&C yellow #10 aluminium lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions or comments?

Call toll free: 1-888-423-0139

Principal Display Panel

LESS DROWSY FORMULA

Motion Sickness II

MECLIZINE HYDROCHLORIDE TABLETS / ANTIEMETIC

  • Provides up to 24 Hours of Protection from Motion Sickness-with Less Drowsiness

TABLETS

25 mg EACH

COMPARE TO DRAMAMINE® LESS DROWSY active ingredient*

*This product is not manufactured or distributed by Prestige Brands, Inc., owner of the registered trademark Dramamine® Less Drowsy Formula.

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL  60007

topcare@topco.com

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Product Label

Top Care Motion Sickness II Tablet

MOTION SICKNESS II 
meclizine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-620
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MECLIZINE HYDROCHLORIDE (MECLIZINE) MECLIZINE HYDROCHLORIDE25  mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE 
SILICON DIOXIDE 
STARCH, CORN 
D&C YELLOW NO. 10 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SODIUM STARCH GLYCOLATE TYPE A CORN 
ALUMINUM OXIDE 
Product Characteristics
ColorYELLOWScoreno score
ShapeROUNDSize9mm
FlavorImprint CodeTCL086
Contains    
Packaging
#Item CodePackage Description
1NDC:36800-620-081 BLISTER PACK in 1 CARTON
18 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33605/31/2013
Labeler - TOP CARE (Topco Associates LLC) (006935977)

 
TOP CARE (Topco Associates LLC)

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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