Active Ingredient (In Each Tablet)
Dimenhydrinate 50 mg
Motion Sickness Relief Tablet
FDA Label NDC 69168-408
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allegiant Health for the product Motion Sickness Relief (NDC 69168-408). 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, use, 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
Use
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
- 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
- marked drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase dizziness
- be careful when driving a motor vehicle or operating machinery
If Pregnant Or Breast-Feeding,
ask a doctor before use.
Keep Out Of Reach Of Children.
In case of accidental 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 ½ to 1 hour before starting activity
- 1 to 2 tables every 4-6 hours
- do not exceed 8 tablets in
24 hours, or as directed by a doctor - ½ to 1 tablet every 6-8 hours
- do not exceed 3 tablets in
24 hours, or as directed by a doctor - ½ tablet every 6-8 hours
- do not exceed 1 ½ tablets
in 24 hours, or as directed by a doctor
| Adults and children 12 years and over | |
| Children 6 to under 12 years | |
| Children 2 to under 6 years |
Other Information
- each tablet contains: calcium 35mg
- do not use ifblister unit is torn or open
- store at room temperature 68-77°F (20-25°C)
- protect from moisture
Inactive Ingredients
croscarmellose sodium, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid
Questions Or Comments?
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Motion Sickness Relief
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