Motion Sickness II by Healthy Accents (DZA Brands, LLC) Drug Facts

Drug Details [pdf]

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

Healthy Accents Motion Sickness II Tablets

MOTION SICKNESS II
meclizine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55316-621
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570)	MECLIZINE HYDROCHLORIDE	25 mg

Ingredient Name	Strength
Inactive Ingredients
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
Color	YELLOW	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	TCL086
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 55316-621-08	8 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/30/2013	12/31/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part336	12/30/2013	12/31/2019

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