Active Ingredient (In Each Chewable Tablet)
Meclizine HCl 25 mg
Motion Sickness Tablet, Chewable
FDA Label NDC 51316-441
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Woonsocket Prescription Center, Incorporated for the product Motion Sickness (NDC 51316-441). 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 chewable 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 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
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic beverages
- 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 right away.
Directions
- do not take more than directed
- dosage should be taken one hour before travel starts
- chew or crush tablets completely before swallowing; do not swallow tablets whole
- adults and children 12 years and over: take 1 to 2 chewable 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
colloidal silicon dioxide, dextrose, FD&C red #40 aluminum lake, flavor, lactose monohydrate, magnesium stearate, pregelatinized starch, propylene glycol, saccharin sodium, silicon dioxide
Questions Or Comments?
1-800-426-9391
Principal Display Panel
CVS™
51316-441-21
UP TO
24
HR
actual size
Raspberry
Flavor
MOTION SICKNESS
Meclizine Hydrochloride, 25 mg Chewable Tablets, Antiemetic
Helps prevent nausea, vomiting | Ages 12 Years
& dizziness due to motion sickness | & Over
16 CHEWABLE
TABLETS
(25 mg EACH)
Compare to Bonine®
Chewable Tablets
active ingredient*
Chew or crush tablets
completely before
swallowing. Do not swallow
tablets whole.
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
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1-800-SHOP CVS V-11112
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50844 ORG082340421
*This product is not
manufactured or distributed
by WellSpring Pharmaceutical
Corporation, owner of the
registered trademark
Bonine® Chewable Tablets.
Cvs 44-404a (Cvs 44 404a 1)
* Please review the disclaimer below.
