Driminate

DIMENHYDRINATE ORAL HUMAN OTC DRUG

Driminate is an FDA drug label for the active ingredient DIMENHYDRINATE manufactured by Major Pharmaceuticals administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260610.

Generic name
DIMENHYDRINATE
Manufacturer
Major Pharmaceuticals
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
0904-2051
Application
M009
Label effective
20260610

About this product

Driminate is an FDA-registered drug product whose active ingredient is DIMENHYDRINATE. It is labelled by Major Pharmaceuticals taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 0904-2051, application M009, label effective 20260610. It is one of 15 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.

What it is used for

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.

Active ingredients

Active ingredient (in each tablet) Dimenhydrinate 50 mg

Indications & Usage

Uses for prevention and treatment of these symptoms associated with motion sickness: nausea vomiting dizziness

Dosage & Administration

Directions do not take more than directed to prevent motion sickness, the first dose should be taken 1/2 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 1/2 tablet every 6-8 hours ■ do not give more than 1 1/2 tablets in 24 hours, or as directed by a doctor

Warnings

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 difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product alcohol, sedatives, and tranquilizers may increase drowsiness marked drowsiness may occur use caution when driving a motor vehicle or operating machinery avoid alcoholic beverages If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

More products with the same ingredient

DIMENHYDRINATE

Airmit Ace

Sato Pharmaceutical Co., Ltd. View label

Dimenhydrinate

CVS Pharmacy, Inc. View label

Dramamine Orange

Medtech Products Inc. View label

Gravol

Church & Dwight Co., Inc. View label

Motion Sickness

CVS Pharmacy View label

Motion Sickness

Geiss, Destin & Dunn Inc. View label

Motion Sickness

Strategic Sourcing Services LLC View label

How products containing DIMENHYDRINATE compare

FDA lists 15 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.

Dosage formProductsManufacturerProducts
— — CVS Pharmacy 1
— — CVS Pharmacy, Inc. 1
— — Cardinal Health 110, LLC. DBA Leader 1
— — Chain Drug Marketing Association, Inc. 1
— — Church & Dwight Co., Inc. 1

Recall and safety notices

5 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.

RecallProductFirmClassStatusReported
D-0702-2026 Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6951-61 Major Pharmaceuticals Class II Ongoing 20260729
D-0709-2026 Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3560-0; NDC Blister: 0904-6951-61 Major Pharmaceuticals Class II Ongoing 20260729
D-0711-2026 Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3563-0; NDC Blister: 0904-6956-61 Major Pharmaceuticals Class II Ongoing 20260729
D-0703-2026 Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6952-61 Major Pharmaceuticals Class II Ongoing 20260729
D-0710-2026 Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal Health, Dublin, OH 43017. NDC Bag: 55154-3562-0; NDC Blister: 0904-6951-61 Major Pharmaceuticals Class II Ongoing 20260729

Frequently asked questions

What is Driminate used for?
Uses for prevention and treatment of these symptoms associated with motion sickness: nausea vomiting dizziness

Who makes Driminate?
Major Pharmaceuticals is the labeler of record for Driminate. 15 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 Driminate 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 Driminate 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. 15 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 Driminate been recalled?
5 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.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.