Active Ingredient (In Each Tablet)
Meclizine HCl 25 mg
Motion Sickness Tablet
FDA Label NDC 37808-903
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by H E B for the product Motion Sickness (NDC 37808-903). 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 1/2 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
- used 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
H.E.B®
NDC 37808-903-12
Compare to
Dramamine®
All Day Less
Drowsy active
ingredient•
Motion
Sickness
Meclizine HCl 25 mg
Antiemetic
Helps prevent Nausea
& Dizziness due to
Motion Sickness for
up to 24 hours
• 24 Hours of
Protection
• Less Drowsy
Formula
100 TABLETS
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
• This product is not manufactured or distributed by Medtech Products Inc., owner of the registered trademark Dramamine® All Day Less Drowsy.
50844 ORG021940
Heb 44-403 (Heb 44 403 1)
* Please review the disclaimer below.
