Active Ingredient (In Each Tablet)
Meclizine HCl 25 mg
Motion Sickness Relief Tablet
FDA Label NDC 50844-403
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by L.n.k. International, Inc. for the product Motion Sickness Relief (NDC 50844-403). 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
- 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 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
- 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, magnesium stearate, silica gel
Questions Or Comments?
1-800-426-9391
Principal Display Panel
Quality
Plus
NDC 50844-403-19
*Compare to the active ingredient
in Dramamine® Less Drowsy Formula
Motion Sickness
Relief LESS DROWSY FORMULA
Meclizine HCl 25 mg • Antiemetic
HELPS PREVENT NAUSEA AND DIZZINESS
DUE TO MOTION SICKNESS
FOR UP TO 24 HOURS
8 Tablets
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
*This product is not manufactured or distributed by
Prestige Brands, Inc., owner of the registered trademark
Dramamine® Less Drowsy Formula.
50844 REV0715B40319
Distributed by
LNK INTERNATIONAL, INC.
60 Arkay Drive
Hauppauge, NY 11788
USA
Quality Plus 44-403 (Quality Plus 44 403 1)
* Please review the disclaimer below.
