Airmit Ace

DIMENHYDRINATE ORAL HUMAN OTC DRUG

Airmit Ace is an FDA drug label for the active ingredient DIMENHYDRINATE manufactured by Sato Pharmaceutical Co., Ltd. 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 20231201.

Generic name
DIMENHYDRINATE
Manufacturer
Sato Pharmaceutical Co., Ltd.
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
49873-802
Application
M009
Label effective
20231201

About this product

Airmit Ace is an FDA-registered drug product whose active ingredient is DIMENHYDRINATE. It is labelled by Sato Pharmaceutical Co., Ltd. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 49873-802, application M009, label effective 20231201. 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: following symptoms, 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 25 mg

Indications & Usage

Uses For the prevention and treatment of the following symptoms associated with motion sickness ■nausea ■vomiting ■dizziness

Dosage & Administration

Directions adults and children 12 years of age and over - oral dosage is 2 to 4 tablets every 4 to 6 hours, not to exceed 16 tablets in 24 hours, or as directed by a doctor children 6 to under 12 years of age - oral dosage is 1 to 2 tablets every 6 to 8 hours, not to exceed 6 tablets in 24 hours, or as directed by a doctor children 2 to under 6 years of age - oral dosage is 1 tablet every 6 to 8 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctor children under 2 years of age - ask a doctor

Warnings

Warnings Do not use ■for children under 2 years of age unless directed by a doctor ■this product if you are taking sedatives or tranquilizers, without first consulting your 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 When using this product ■may cause marked drowsiness: alcohol, sedatives, and tranquilizers may increase the drowsiness effect ■avoid alcoholic beverages ■use caution when driving a motor vehicle or operating machinery If pregnant or breast-feeding , ask a health professional before use. Keep our of reach of children . In case of over dose, get medical help or contact a Poison Control Center right away.

More products with the same ingredient

DIMENHYDRINATE

Dimenhydrinate

CVS Pharmacy, Inc. View label

Dramamine Orange

Medtech Products Inc. View label

Driminate

Major Pharmaceuticals View label

Gravol

Church & Dwight Co., Inc. View label

Motion Sickness

Geiss, Destin & Dunn Inc. View label

Motion Sickness

Strategic Sourcing Services LLC View label

Motion Sickness

CVS Pharmacy 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

Frequently asked questions

What is Airmit Ace used for?
Uses For the prevention and treatment of the following symptoms associated with motion sickness ■nausea ■vomiting ■dizziness

Who makes Airmit Ace?
Sato Pharmaceutical Co., Ltd. is the labeler of record for Airmit Ace. 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 Airmit Ace 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 Airmit Ace 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 Airmit Ace been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

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.