Label: MOTION SICKNESS II- meclizine hydrochloride 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
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- Active ingredient (in each tablet)
Meclizine HCl 25 mgClose
- for prevention and treatment of these symptoms associated with motion sickness:
Ask a doctor before use if
- difficulty in urination due to an enlargement of the prostate gland
- a breathing problems such as emphysema or chronic bronchitis
When using this product
- drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful 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 right away.
- to prevent motion sickness, take the fitst 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
- store at controlled room temperature 15º-30ºC (59º-86ºF)
- protect from heat and humidity
- used by expiration date on package
- Inactive ingredients
corn starch, D&C yellow #10 aluminum lake, lactose, magnesium stearate, silica gelClose
- Questions or comments?
- Principal Display Panel
Motion Sickness II
Meclizine 25 mg Each
LESS DROWSY FORMULA
Helps prevent nausea, vomiting and dizziness due to motion sickness.
*Compare to the active ingredient in Dramamine® Less Drowsy Formula
* This product is not manufactured or distributed by Prestige Brands Inc., owner of the registered trademark Dramamine® Less Drowsy Formula.
Great Lakes Wholesale & Marketing L.L.C.
3729 Patterson Ave., S.E.
Grand Rapids, MI 49512
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF A 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 LABEL Item Code (Source) NDC:64092-608 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MECLIZINE HYDROCHLORIDE (MECLIZINE) MECLIZINE HYDROCHLORIDE 25 mg Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 LACTOSE MAGNESIUM STEARATE Product Characteristics Color YELLOW Score no score Shape ROUND Size 10mm 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 1 8 in 1 BLISTER PACK 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, 64092-608) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(64092-608, 64092-608)