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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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.

airmitacePDP.jpgPDP

airmitacecart.jpgCarton


AIRMIT ACE 
dimenhydrinate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-802
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
dimenhydrinate (dimenhydrinate) dimenhydrinate25 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
FD&C YELLOW NO. 6 
HYDROXYPROPYL CORN STARCH (5% SUBSTITUTION BY WEIGHT) 
HYDROXYPROPYL CELLULOSE 
LACTOSE 
MAGNESIUM STEARATE 
MANNITOL 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE 
SUCROSE 
Product Characteristics
ColorwhiteScore no score
ShapeROUNDSize9mm
FlavorImprint Code ;
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:49873-802-011 BLISTER PACK ( BLISTER PACK) in 1 CARTONcontains a BLISTER PACK
16 TABLET ( TABLET) in 1 BLISTER PACKThis package is contained within the CARTON (49873-802-01)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33603/11/2005

Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
Establishment
NameAddressID/FEIOperations
Sato Pharmaceutical Co., Ltd.715699133manufacture, label, pack

Revised: 01/2012 Sato Pharmaceutical Co., Ltd.