Otc - Active Ingredient
Active ingredient (in each tablet)
Dimenhydrinate 25 mg
Airmit Ace Tablet
FDA Label NDC 49873-802
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sato Pharmaceutical Co., Ltd. for the product Airmit Ace (NDC 49873-802). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Antiemetic
Indications & Usage
Uses
For the prevention and treatment of the following symptoms associated with motion sickness
■nausea ■vomiting ■dizziness
Warnings
Warnings
Otc - Do Not Use
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
Otc - Ask 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
Otc - When Using
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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep our of reach of children. In case of over dose, get medical help or contact a Poison Control Center right away.
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
Other Safety Information
Other information
■each tablet contains: calcium 5mg
Inactive Ingredient
Inactive ingredients Dibasic calcium phosphate, FD and C Yellow No. 6, hydroxypropyl cellulose, hydroxypropyl starch, lactose, magnesium stearate, mannitol, microcrystalline cellulose, povidone, sugar.
Package Label.Principal Display Panel
airmitacePDP.jpg
airmitacecart.jpg
Carton (Airmitacecart)
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