MOTION SICKNESS II- meclizine hcl tablet 
Healthy Accents (DZA Brands, LLC)

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

for prevention and treatment of these symptoms associated with motion sickness:

  • nausea
  • vomiting
  • dizziness

Warnings

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

Ask a doctor before use if you have

  • 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 beverages
  • 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 care 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 of age and over: take 1 to 2 tablets once daily or as directed by a doctor
  • do not exceed 2 tablets in 24 hours
  • not for frequent or prolonged use except on the advice of a doctor
  • do not exceed recommended dosage

Other information

  • VERY LOW SODIUM
  • store at 15º-30ºC (59º-86ºF) protect from heat and humidity

Inactive ingredients

anhydrous lactose, colloidal silicon dioxide, corn starch, D&C Yellow# 10 Aluminium Lake, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

Questions or comments?

Call toll free 1-866-322-2439

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*Compare to Dramamine® Less Drowsy Formula active ingredient

Motion Sickness II

Less Drowsy Formula

Meclizine Hydrochloride 25 mg

prevents up to 24 hours of motion sickness

Tablets

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

DO NOT USE IF IMPRINTED FOIL UNDER CAP IS BROKEN OR MISSING

DISTRIBUTED BY: DZA BRANDS, LLC

Salisbury, NC 28147

Scarborough, ME 04074

Product Label

Meclizine HCl 25 mg

Healthy Accents Motion Sickness II Tablets

MOTION SICKNESS II 
meclizine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-621
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
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
Product Characteristics
ColorYELLOWScoreno score
ShapeROUNDSize9mm
FlavorImprint Code TCL086
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55316-621-088 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/30/201312/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33612/30/201312/31/2019
Labeler - Healthy Accents (DZA Brands, LLC) (090322194)

Revised: 11/2019
Document Id: 98f19144-ea4d-48f9-8f30-ffa4951bff63
Set id: 22a3e53f-8a22-4719-afc3-cfa86ecb8c48
Version: 2
Effective Time: 20191105
 
Healthy Accents (DZA Brands, LLC)