Active Ingredient (In Each Tablet)
Dimenhydrinate 50 mg
Gravol Tablet, Coated
FDA Label NDC 10237-941
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Church & Dwight Co., Inc. for the product Gravol (NDC 10237-941). 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 taking, 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 or any activity that requires alertness
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
- to prevent or treat motion sickness, see below:
- take 1 to 2 tablets every 4-6 hours
- do not take more than 8 tablets in 24 hours, or as directed by a doctor
- give 1/2 to 1 tablet every 6-8 hours
- do not give more than 3 tablets in 24 hours, or as directed by a doctor
- give 1/4 to 1/2 tablet every 6-8 hours
- do not give more than 1-1/2 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
- store at room temperature 59°-77°F (15°-25°C)
- do not use if packet is torn
Inactive Ingredients
Corn starch, croscarmellose sodium, FD&C yellow 6 aluminum lake, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide
Questions Or Comments?
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OVER 70 YEARS OF
QUALITY & TRUST†
Prevents and Treats:
Nausea & Vomiting
Dizziness*
*Prevention and treatment of nausea,
vomiting and dizziness due to motion sickness
Gravol™ COATED TABLETS
Gravol™
MOTION SICKNESS RELIEF
Dimenhydrinate 50 mg Tablets - Antiemetic
10
COATED TABLETS
TASTE FREE
EASY TO SWALLOW
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