Drug Facts
Active ingredient (in each tablet)
Meclizine HCl 25 mg
Meclizine Hydrochloride Tablet
FDA Label NDC 69842-857
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 Pharmacy, Inc for the product Meclizine Hydrochloride (NDC 69842-857). 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 drug facts, otc - purpose, uses, do not give to, ask a doctor before use if you have, ask a doctor or pharmacist before use if you, when using this product, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Antiemetic
Uses
for prevention and treatment of these symptoms associated with motion sickness:
■ nausea ■ vomiting ■ dizziness
Do Not Give To
children under 12 years of age unless directed by a doctor.
Ask A Doctor Before Use If You Have
■ a breathing problem such as emphysema or chronic bronchitis
■ glaucoma
■ trouble urinating due to an enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You
are taking sedatives or tranquilizers.
When Using This Product
■ drowsiness may occur
■ avoid alcoholic drinks
■ alcohol, sedatives, and tranquilizers may increase drowsiness
■ be careful when driving a motor vehicle or operating machinery
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a doctor before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
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 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
store at room temperature 20°–25°C (68°–77°F)
Inactive Ingredient
corn starch, colloidal silicon dioxide, D&C yellow #10 aluminum lake, lactose, magnesium stearate, microcrystalline cellulose
Otc - Questions
Questions? 1-800-231-4670
Other
KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2020 CVS/pharmacy
CVS.com® 1-800-SHOP CVS V-30287
*This product is not manufactured or distributed by Prestige Brands, Inc., owner of the registered trademark Dramamine® Less Drowsy Formula.
Package Label.Principal Display Panel
CVSHealth
Compare to the active ingredient in Dramamine® Less Drowsy Formula*
Motion Sickness
Less Drowsy Formula
MECLIZINE HYDROCHLORIDE TABLETS
Antiemetic
Prevents up to 24 hours of
motion sickness
• Protection with less drowsiness
• Prevents nausea, vomiting
& dizziness
16 TABLETS (25 mg EACH)
* Please review the disclaimer below.
