Label: AIRMIT ACE- dimenhydrinate tablet
- NDC Code(s): 49873-802-01
- Packager: Sato Pharmaceutical Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 1, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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
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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
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AIRMIT ACE
dimenhydrinate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49873-802 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMENHYDRINATE (UNII: JB937PER5C) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIMENHYDRINATE 25 mg Inactive Ingredients Ingredient Name Strength 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 Color white Score no score Shape ROUND Size 9mm Flavor Imprint Code SATO;7 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49873-802-01 1 in 1 CARTON 03/11/2005 1 6 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M009 03/11/2005 Labeler - Sato Pharmaceutical Co., Ltd. (690575642) Establishment Name Address ID/FEI Business Operations Sato Pharmaceutical Co., Ltd. 715699133 manufacture(49873-802) , label(49873-802) , pack(49873-802)
