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| Product NDC Code | 10237-942 | ||||
|---|---|---|---|---|---|
| Drug Name | Gravol |
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| Type | Brand | ||||
| Pharm Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | SYRUP | ||||
| RxCUI drug identifier | 755901, 2594768 |
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| Application Number | M009 | ||||
| Labeler Name | Church & Dwight Co., Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each 5 mL) Dimenhydrinate 15 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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: children 2 to 6 years 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 children 6 to under 12 years 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 |
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| children 6 to under 12 years |
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Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Citric acid, flavor, polysorbate 80, propylene glycol, sodium benzoate, sorbitol, sucrose, water
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Use For prevention and treatment of these symptoms associated with motion sickness: nausea vomiting dizziness
Purpose
Information about the drug product’s indications for use.Purpose Antiemetic
Spl product data elements
Usually a list of ingredients in a drug product.Gravol Dimenhydrinate DIMENHYDRINATE DIPHENHYDRAMINE ANHYDROUS CITRIC ACID SUCROSE PROPYLENE GLYCOL WATER POLYSORBATE 80 SODIUM BENZOATE SORBITOL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Other information store at room temperature 59º-77ºF (15º-25ºC) do not use if packet is torn
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.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 doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use for children under 2 years of age unless directed by a doctor.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-800-952-5080 M-F 9am to 5pm ET
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.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
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a doctor before use.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings 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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API