Airmit Ace

Airmit Ace
SPL v5
SPL
SPL Set ID a98d252d-4cfa-496a-ab2c-627f45f0d7d9
Route
ORAL
Published
Effective Date 2019-08-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
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

Identifiers & Packaging

Pill Appearance
Imprint: SATO;7 Shape: round Color: white Size: 9 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2005-03-11

Description

Active ingredient (in each tablet) Dimenhydrinate 25 mg


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

For the prevention and treatment of the following symptoms associated with motion sickness

■nausea  ■vomiting  ■dizziness

Dosage and 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

Description

Active ingredient (in each tablet) Dimenhydrinate 25 mg

Section 50565-1

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

Section 50567-7

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



Section 50569-3

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



Section 50570-1

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



Section 51727-6

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



Section 51945-4

Section 53414-9

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



Section 55105-1

Purpose

Antiemetic

Section 55106-9

Active ingredient (in each tablet)

Dimenhydrinate 25 mg

Section 60561-8

Other information

■each tablet contains: calcium 5mg




Structured Label Content

Indications and Usage (34067-9)

Uses

For the prevention and treatment of the following symptoms associated with motion sickness

■nausea  ■vomiting  ■dizziness

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

Warnings

Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)

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



Section 50569-3 (50569-3)

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



Section 50570-1 (50570-1)

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



Section 51727-6 (51727-6)

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



Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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



Section 55105-1 (55105-1)

Purpose

Antiemetic

Section 55106-9 (55106-9)

Active ingredient (in each tablet)

Dimenhydrinate 25 mg

Section 60561-8 (60561-8)

Other information

■each tablet contains: calcium 5mg




Advanced Ingredient Data


Raw Label Data

All Sections (JSON)