Active Ingredient (In Each Tablet)
Meclizine HCl 25 mg
Motion Sickness Relief Tablet
FDA Label NDC 36800-943
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates, Llc for the product Motion Sickness Relief (NDC 36800-943). 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
- difficulty in urination due to enlargement of the prostate gland
- glaucoma
- 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
- drowsiness may occur
- avoid alcoholic beverages
- alcohol, sedatives, and tranquilizers may increase drowsiness
- use caution when driving a motor vehicle or operating machinery
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 ½ 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
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- 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 anhydrous, magnesium stearate, silicon dioxide
Questions Or Comments?
1-888-423-0139
Principal Display Panel
TopCare
Health™
NDC 36800-943-19
COMPARE TO DRAMAMINE®
ALL DAY LESS DROWSY
ACTIVE INGREDIENT
LESS DROWSY FORMULA
Motion Sickness Relief
MECLIZINE HCl, 25 mg - ANTIEMETIC
LONG LASTING:
• Up to 24 Hours of Protection
• Prevents Nausea,
Dizziness and Vomiting
up to
24
HOURS
•Our Pharmacist Recommends•
8 TABLETS
actual size
TAMPER EVIDENT: DO NOT USE IF
PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING
DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
©TOPCO LNKA0319 QUESTIONS? 1-888-423-0139
[email protected] www.topcarebrand.com
*This product is not manufactured or distributed by Medtech Products Inc.,
owner of the registered trademark Dramamine® All Day Less Drowsy.
50844 ORG021940319
QUALITY
GUARANTEED
Topcare 44-403 (Topcare 44 403 1)
* Please review the disclaimer below.
