Label: LESS DROWSY FORMULA MOTION SICKNESS RELIEF- meclizine hcl tablet
- NDC Code(s): 57243-403-02
- Packager: Salado 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 May 19, 2018
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- Active ingredient (in each tablet)
Meclizine HCl 25 mgClose
for the 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 problems 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
- protect from heat and humidity
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- used by expiration date on package
- Inactive ingredients
corn starch, D&C yellow #10 aluminum lake, lactose, magnesium stearate, silica gelClose
- Questions of comments?
- Principal Display Panel
LESS DROWSY FORMULA
LESS DROWSY FORMULA
MECLIZINE HCl TABLETS 25 mg/ANTIEMETIC
HELPS PREVENT NAUSEA & DIZZINESS
DUE TO MOTION SICKNESS FOR
UP TO 24 HOURS
TAMPER EVIDENT: Use Only if This Blister is Intact.
*This product is not manufactured or distributed by Prestige Brands, Inc., owner of the registered trademark
Dramamine® Less Drowsy Formula. 50844 REV0715B40302
Distributed by Salado Sales, Inc., P.O. Box 6115, Temple, Texas 76503 www.CVPproducts.com
- INGREDIENTS AND APPEARANCE
LESS DROWSY FORMULA MOTION SICKNESS RELIEF
meclizine hcl tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57243-403 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) LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 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:57243-403-02 1 in 1 PACKAGE 06/24/2002 1 12 in 1 BOTTLE, PLASTIC; 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 - Salado Sales, Inc. (009830555) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(57243-403) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(57243-403) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 PACK(57243-403)