Label: MOTION SICKNESS II- meclizine hcl tablet
- NDC Code(s): 64092-608-08
- Packager: GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated July 27, 2016
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- Active ingredient (in each tablet)
Meclizine HCl 25 mgClose
for prevention and treatment of nausea, vomiting, or dizziness associated with motion sicknessClose
Ask a doctor before use if you have
- difficulty in urination due to an enlargement of the prostate gland
- a breathing problem such as emphysema or chronic bronchitis
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
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
- to prevent motion sickness, take the first dose one hour before starting activity
- to prevent or treat motion sickness: 1 to 2 tablets once daily for adults and children 12 years and over, or as directed by a doctor
- Other information
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- protect from heat and humidity
- see end flap for expiration date and lot number
- Inactive ingredients
corn starch, D&C yellow #10 aluminum lake, lactose, magnesium stearate, silica gelClose
- Questions or comments?
- Principal Display Panel
*Compare to the active ingredient in Dramamine® Less Drowsy Formula
Motion Sickness II
Meclizine 25 mg Each
LESS DROWSY FORMULA
Helps prevent nausea, vomiting and dizziness
due to motion sickness.
*This product is not manufactured or distributed by Prestige Brands, Inc., owner of the registered trademark Dramamine® Less Drowsy Formula.
Distributed by: Great Lakes Wholesale & Marketing L.L.C.
3729 Patterson Ave., S.E., Grand Rapids, MI 49512
If you are not completely satisfied with this product, regardless of reason, return your unused portion to Great Lakes Wholesale for a full refund
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
- INGREDIENTS AND APPEARANCE
MOTION SICKNESS II
meclizine hcl tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64092-608 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE 25 mg Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color YELLOW Score no score Shape ROUND Size 9mm Flavor Imprint Code 44;403 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64092-608-08 1 in 1 CARTON 06/24/2002 1 8 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part336 06/24/2002 Labeler - GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. (361925498) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(64092-608) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(64092-608)