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.

Active Ingredient

Active ingredient (in each tablet)

Meclizine HCl 25 mg

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 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

Warnings and Precautions (34071-1)

Warnings

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

Active Ingredient (55106-9)

Active ingredient (in each tablet)

Meclizine HCl 25 mg

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.

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 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)