Active Ingredient (In Each 5 Ml)
Dimenhydrinate 15 mg
Gravol Syrup
FDA Label NDC 10237-942
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 10237-942). 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 5 ml), 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 teaspoon (5 mL) every 4-6 hours
- do not take more than 5 teaspoons (25 mL) in 24 hours, or as directed by a doctor
- give 2 teaspoons (10 mL) every 6-8 hours
- do not give more than 10 teaspoons (50 mL) in 24 hours, or as directed by a doctor
| children 2 to 6 years | |
| children 6 to under 12 years |
Other Information
- store at room temperature 59°-77°F (15°-25°C)
- do not use if packet is torn
Inactive Ingredients
Citric acid, flavor, polysorbate 80, propylene glycol, sodium benzoate, sorbitol, sucrose, water
Questions Or Comments?
1-800-952-5080 M-F 9am to 5pm ET
Principal Display Panel
OVER 70 YEARS OF
QUALITY & TRUST†
Children 2+
Prevents and Treats:
Nausea & Vomiting
Dizziness*
kids Gravol™
MOTION SICKNESS RELIEF
Dimenhydrinate 15 mg Syrup - Antiemetic
*Prevention and treatment of
nausea, vomiting and dizziness
due to motion sickness
MIXED FRUIT
FLAVOR
DYE FREE ALCOHOL FREE
2.5 FL OZ (75 mL)
Church & Dwight Co., Inc.,
Ewing, NJ 08628
Gravol is a trademark of
Church & Dwight Canada Corp.
Made in Canada
GRFC-00164-01 72022778
Abase_2_qcpdf2129433_r6.jpg (Abase 2 Qcpdf2129433 R6)
* Please review the disclaimer below.
