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 March 12, 2019
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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 enlargement of the prostate gland
- a breathing problem such as emphysema or chronic bronchitis
When using this product
- alcohol, sedatives, and tranquilizers may increase drowsiness
- drowsiness may occur
- use caution when driving a motor vehicle or operating machinery
- avoid alcoholic beverages
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 1/2 hour to 1 hour before starting activity
- to treat motion sickness, take at first signs of symptoms
- adults and children 12 years and over: 1 to 2 tablets once daily, or as directed by a doctor
- Other information
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- protect from heat and humidity
- use by expiration date on package
- Inactive ingredients
corn starch, D&C yellow #10 aluminum lake, lactose anhydrous, magnesium stearate, silicon dioxideClose
- Questions of comments?
- Principal Display Panel
ALL DAY LESS DROWSY
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 Medtech Products Inc., owner of the registered trademark
Dramamine® All Day Less Drowsy.
Distributed by Consumer Value Products, Inc.
P.O. Box 6115, Temple, Texas 76502
- 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) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) 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)