Airmit Ace

Manufacturer: Sato Pharmaceutical Co., Ltd.
Effective date: 2023-12-01
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-06-01 00:03:14

Label at a glance#

ProductAirmit Ace

Active ingredientDIMENHYDRINATE

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)
Dimenhydrinate 25 mg

OTC - PURPOSE SECTION

Purpose
Antiemetic

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings

OTC - DO NOT USE SECTION

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 SECTION

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 SECTION

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 SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep our of reach of children. In case of over dose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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

carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1241485	Airmit Ace 25 MG Oral Tablet	PSN	5
198602	dimenhyDRINATE 25 MG Oral Tablet	PSN	5
1241485	dimenhydrinate 25 MG Oral Tablet [Airmit]	SBD	5
198602	dimenhydrinate 25 MG Oral Tablet	SCD	5
1241485	Airmit 25 MG Oral Tablet	SY	5

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DIPHENHYDRAMINE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49873-802-01	Airmit Ace	1 in 1 CARTON	TABLET	1		5
49873-802-01	Airmit Ace	6 in 1 BLISTER PACK	TABLET	6		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49873-802	AIRMIT ACE (DIMENHYDRINATE) TABLET [SATO PHARMACEUTICAL CO., LTD.]	5	Current NDC, Legacy NDC, 2 package rows	20231203_a98d252d-4cfa-496a-ab2c-627f45f0d7d9.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
dimenhydrinate	ACTIVE INGREDIENT	JB937PER5C	2
dimenhydrinate	ACTIVE MOIETY	JB937PER5C	2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	2
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	2
HYDROXYPROPYL CORN STARCH (5% SUBSTITUTION BY WEIGHT)	INACTIVE INGREDIENT	9M44R3409A	2
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

Airmit Ace
dimenhydrinate
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
DIPHENHYDRAMINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
49873-802	49873-802-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	L11K75P92J	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
HYDROXYPROPYL CORN STARCH (5% SUBSTITUTION BY WEIGHT)	9M44R3409A	IACT
HYDROXYPROPYL CELLULOSE	RFW2ET671P	IACT
LACTOSE	J2B2A4N98G	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MANNITOL	3OWL53L36A	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
POVIDONE	FZ989GH94E	IACT
SUCROSE	C151H8M554	IACT
DIMENHYDRINATE	JB937PER5C	ACTIB

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 18 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL		6184 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET / ORAL		4249 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / ORAL	2500 mg		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET / ORAL		216 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	TABLET / ORAL		2240 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET / ORAL		3391 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET / ORAL		3391 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET / ORAL	60.02 mg		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / ORAL	2500 mg		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET / ORAL		216 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET / ORAL		230 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET / ORAL	60.02 mg		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	TABLET / ORAL		2240 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL		6184 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET / ORAL		230 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET / ORAL		4249 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Airmit Ace	DIMENHYDRINATE	Sato Pharmaceutical Co., Ltd.	a98d252d-4cfa-496a-ab2c-627f45f0d7d9	2023-12-01	Warnings	Exact identifier ndc (package): 49873-802-01 ndc (product): 49873-802 ndc11 (package): 49873080201 spl id: 0b7d81d6-f5ac-a151-e063-6294a90a8322 spl set id: a98d252d-4cfa-496a-ab2c-627f45f0d7d9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.