Active Ingredient (In Each Tablet)
Dimenhydrinate 50 mg
Motion Sickness Relief Tablet
FDA Label NDC 49035-981
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wal-mart Stores Inc for the product Motion Sickness Relief (NDC 49035-981). 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 prevention and treatment of these symptoms associated with motion sickness:
- nausea
- vomiting
- dizziness
Do Not Use
for children under 2 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
- difficulty in urination due to 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 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, the first dose should be taken one-half to one hour before starting activity
| adults and children 12 years and over | 1 to 2 tablets every 4-6 hours; do not exceed 8 tablets in 24 hours, or as directed by a doctor |
| children 6 to under 12 years | 1/2 to 1 tablet every 6-8 hours; do not exceed 3 tablets in 24 hours, or as directed by a doctor |
| children 2 to under 6 years | 1/2 tablet every 6-8 hours; do not exceed 1 1/2 tablets in 24 hours, or as directed by a doctor |
Other Information
- each tablet contains: calcium 35 mg
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- protect from moisture
- use by expiration date on package
Inactive Ingredients
croscarmellose sodium, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid
Questions?
1-888-287-1915
Principal Display Panel
NDC 49035-981-12
equate™
Compare to
Dramamine®
Original Formula
Active
Ingredient*
Motion
Sickness Relief
Dimenhydrinate 50 mg
Antiemetic
• Prevents nausea,
dizziness & vomiting
100
TABLETS
Actual Size
TAMPER EVIDENT: DO NOT USE IF
IMPRINTED SAFETY SEAL UNDER CAP
IS BROKEN OR MISSING
DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716
PRODUCT OF CHINA AND ITALY
*This product is not manufactured or distributed by Medtech Products Inc., owner of the registered trademark Dramamine® Original Formula.
50844 REV0518B19812
Equate 44-198 (Equate 44 198 1)
* Please review the disclaimer below.
