Active Ingredient (In Each Tablet)
Dimenhydrinate 50 mg
Motion Sickness Relief Tablet
FDA Label NDC 46122-536
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Amerisource Bergen for the product Motion Sickness Relief (NDC 46122-536). 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
- 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 | ½ 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 | ½ tablet every 6-8 hours; do not exceed 1½ 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
Principal Display Panel
GOOD
NEIGHBOR
PHARMACY®
NDC 46122-536-53
Compare to Dramamine® Original
Formula active ingredient*
Motion Sickness Relief
dimenhydrinate 50 mg / antiemetic
Original Formula
Fast Acting Relief of Motion Sickness for
Children & Adults
12 Tablets ι 50 mg Each
Actual Size
*This product is not manufactured or distributed by Prestige Brands, Inc., owner
of the registered trademark Dramamine® Original Formula.
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
50844 ORG111519802
Distributed By
AmerisourceBergen
1300 Morris Drive
Chesterbrook, PA 19087
Questions or Concerns?
www.mygnp.com
Gnp 44-198 (Good Neighbor Pharmacy 44 198 1)
* Please review the disclaimer below.
