Active Ingredient (In Each Tablet)
Meclizine HCl 25 mg
Less Drowsy Formula Motion Sickness Relief Tablet
FDA Label NDC 57243-403
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Salado Sales, Inc. for the product Less Drowsy Formula Motion Sickness Relief (NDC 57243-403). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiemetic
Uses
for the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness
Do Not Use
for children under 12 years of age unless directed by a doctor.
Ask A Doctor Before Use If You Have
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
- a breathing problem such as emphysema or chronic bronchitis
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers.
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
If Pregnant Or Breast-Feeding,
ask a health professional before use.
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.
Directions
- 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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- 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 dioxide
Questions Of Comments?
1-800-426-9391
Principal Display Panel
CVP®
Health
COMPARE TO
DRAMAMINE®
ALL DAY LESS DROWSY
ACTIVE INGREDIENT*
LESS DROWSY FORMULA
MOTION SICKNESS
RELIEF
MECLIZINE HCl TABLETS 25 mg/ANTIEMETIC
HELPS PREVENT NAUSEA & DIZZINESS
DUE TO MOTION SICKNESS FOR
UP TO 24 HOURS
12 TABLETS
ACTUAL SIZE
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.
50844 REV0219C40302
Distributed by Consumer Value Products, Inc.
P.O. Box 6115, Temple, Texas 76502
CVPproducts.com
Cvp 44-403 (Cvp 44 403 1)
* Please review the disclaimer below.
