Physicianscare Motion Sickness

Physicianscare Motion Sickness
SPL v2
SPL
SPL Set ID c4d3ea22-7c22-7311-e053-2a95a90a779c
Route
ORAL
Published
Effective Date 2021-06-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Meclizine (25 mg)
Inactive Ingredients
Starch, Corn Silicon Dioxide Magnesium Stearate D&c Yellow No. 10 Aluminum Lake Anhydrous Lactose

Identifiers & Packaging

Pill Appearance
Imprint: 44;403 Shape: round Color: yellow Size: 9 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-06-18

Description

Active ingredient (in each tablet) Meclizine HCl 25 mg


Medication Information

Warnings and Precautions

Warnings

Do not use for children under 12 years of age unless directed by a doctor.

Indications and Usage

Uses

for the prevention and treatment of the nausea, vomiting, or dizziness associated with motion sickness.

Dosage and Administration

Directions

■ to prevent motion sickness, take the first dose ½ hour to 1 hour before starting activity

■ to treat motion sickness, take at first signs of symptoms

Adults and children: (12 years and older) 1 to 2 tablets once daily, or as directed by a doctor.

Children under 12 years: Do not give to children under 12 years of age.

Description

Active ingredient (in each tablet) Meclizine HCl 25 mg

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center



(1-800-222-1222) right away.

Section 50567-7

When using this product

■ drowsiness may occur

■ avoid alcoholic beverages

■ alcohol, sedatives and tranquilizers may increase drowsiness

■ use caution when driving a motor vehicle or operating machinery

Section 50568-5

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

Section 50569-3

Ask a doctor before use if you have

■ difficulty in urination due to enlargement of the prostate gland

■ glaucoma

■ a breathing problems such as emphysema or chronic bronchitis

Section 51727-6

Inactive ingredients

corn starch, D&C yellow # 10 aluminum lake, lactose anhydrous, magnesium stearate, silicon dioxide

Section 51945-4

label image

Section 53413-1

Questions or comments? 1-800-835-2263

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)

Meclizine HCl 25 mg

Section 60561-8

Other information

■ tamper-evident sealed packets

■ do not use any opened or torn packets

■ store at 77°F (25°C); excursions permitted between 59- 86º F (15-30ºC)

■ protect from heat and humidity

■ use by expiration date on packet


Structured Label Content

Indications and Usage (34067-9)

Uses

for the prevention and treatment of the nausea, vomiting, or dizziness associated with motion sickness.

Dosage and Administration (34068-7)

Directions

■ to prevent motion sickness, take the first dose ½ hour to 1 hour before starting activity

■ to treat motion sickness, take at first signs of symptoms

Adults and children: (12 years and older) 1 to 2 tablets once daily, or as directed by a doctor.

Children under 12 years: Do not give to children under 12 years of age.

Warnings and Precautions (34071-1)

Warnings

Do not use for children under 12 years of age unless directed by a doctor.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center



(1-800-222-1222) right away.

Section 50567-7 (50567-7)

When using this product

■ drowsiness may occur

■ avoid alcoholic beverages

■ alcohol, sedatives and tranquilizers may increase drowsiness

■ use caution when driving a motor vehicle or operating machinery

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

Section 50569-3 (50569-3)

Ask a doctor before use if you have

■ difficulty in urination due to enlargement of the prostate gland

■ glaucoma

■ a breathing problems such as emphysema or chronic bronchitis

Section 51727-6 (51727-6)

Inactive ingredients

corn starch, D&C yellow # 10 aluminum lake, lactose anhydrous, magnesium stearate, silicon dioxide

Section 51945-4 (51945-4)

label image

Section 53413-1 (53413-1)

Questions or comments? 1-800-835-2263

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)

Meclizine HCl 25 mg

Section 60561-8 (60561-8)

Other information

■ tamper-evident sealed packets

■ do not use any opened or torn packets

■ store at 77°F (25°C); excursions permitted between 59- 86º F (15-30ºC)

■ protect from heat and humidity

■ use by expiration date on packet


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)