Gravol

Gravol is an FDA-registered drug product whose active ingredient is DIMENHYDRINATE. It is labelled by Church & Dwight Co., Inc. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 10237-941, application M009, label effective 20220303. It is one of 2 FDA drug label records sharing the active ingredient DIMENHYDRINATE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing DIMENHYDRINATE are most often described in connection with: symptoms associated, motion sickness, nausea vomiting. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Use For prevention and treatment of these symptoms associated with motion sickness: nausea vomiting dizziness

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: adults and children 12 years and over: 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 children 6 to under 12 years: 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 children 2 to under 6 years: 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

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.

FDA lists 2 drug label records with DIMENHYDRINATE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

2 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Gravol used for?
Use For prevention and treatment of these symptoms associated with motion sickness: nausea vomiting dizziness

Who makes Gravol?
Church & Dwight Co., Inc. is the labeler of record for Gravol. 2 FDA label records share the active ingredient DIMENHYDRINATE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Gravol come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Gravol prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing DIMENHYDRINATE?
Yes. 2 FDA drug label records list DIMENHYDRINATE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Gravol been recalled?
2 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.