AIRMIT ACE- dimenhydrinate tablet 
Sato Pharmaceutical Co., Ltd.

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Airmit Ace

Active ingredient (in each tablet)
Dimenhydrinate 25 mg

Purpose
Antiemetic

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

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.

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 information
■each tablet contains: calcium 5mg

Inactive ingredients  Dibasic calcium phosphate, FD and C Yellow No. 6, hydroxypropyl cellulose, hydroxypropyl starch, lactose, magnesium stearate, mannitol, microcrystalline cellulose, povidone, sugar.

carton

AIRMIT ACE 
dimenhydrinate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-802
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMENHYDRINATE (UNII: JB937PER5C) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIMENHYDRINATE25 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYDROXYPROPYL CORN STARCH (5% SUBSTITUTION BY WEIGHT) (UNII: 9M44R3409A)  
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
LACTOSE (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize9mm
FlavorImprint Code SATO;7
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49873-802-011 in 1 CARTON03/11/2005
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00903/11/2005
Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
Establishment
NameAddressID/FEIBusiness Operations
Sato Pharmaceutical Co., Ltd.715699133manufacture(49873-802) , label(49873-802) , pack(49873-802)

Revised: 12/2023
Document Id: 0b7d81d6-f5ac-a151-e063-6294a90a8322
Set id: a98d252d-4cfa-496a-ab2c-627f45f0d7d9
Version: 5
Effective Time: 20231201
 
Sato Pharmaceutical Co., Ltd.