Active Ingredient (In Each Tablet)
Dimenhydrinate 50 mg
Motion Sickness Tablet
FDA Label NDC 59779-198
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 for the product Motion Sickness (NDC 59779-198). 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 2 years of age unless directed by a doctor.
Ask A Doctor Before Use If You Have
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- difficulty in urination due to an enlargement of the prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers.
When Using This Product
- marked drowsiness may occur
- avoid alcoholic drinks
- 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, the first dose should be taken one-half to one hour before starting activity
- adults and children 12 years of age and over: 1 to 2 tablets every 4-6 hours; not to exceed 8 tablets in 24 hours, or as directed by a doctor
- children 6 to under 12 years of age: 1/2 to 1 tablet every 6-8 hours; not to exceed 3 tablets in 24 hours, or as directed by a doctor
- children 2 to under 6 years of age: 1/2 tablet every 6-8 hours; not to exceed 1 1/2 tablets in 24 hours, 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 moisture
- see end flap for expiration date and lot number
Inactive Ingredients
croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silica gel, stearic acid
Questions Or Comments?
1-800-426-9391
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Compare to the active ingredient
in Dramamine® Tablets*
Original Formula
NDC 59779-198-07
Motion Sickness
DIMENHYDRINATE TABLETS
Antiemetic
• Fast acting motion sickness relief
• For children & adults
Actual Size
36 TABLETS (50 mg EACH)
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® Tablets.
50844 ORG101319807
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
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Cvs 44-198 (Cvs 44 198 1)
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