Medique Medi-meclizine

Medique Medi-meclizine
SPL v7
SPL
SPL Set ID b3fec2df-c41d-0b56-e053-2995a90a35e8
Route
ORAL
Published
Effective Date 2022-06-30
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 Lactose Monohydrate

Identifiers & Packaging

Pill Appearance
Imprint: 44;403 Shape: round Color: yellow Size: 9 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-12-14

Description

Active ingredient (in each tablet) Meclizine Hydrochloride 25 mg


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

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

Dosage and Administration

Directions

  • Do not take more than directed
  • take the first dose ½ hour to 1 hour before starting activity

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 Hydrochloride 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 50570-1

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

Section 51727-6

Inactive ingredients

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

Section 53413-1

Questions or comments? Call 1-800-634-7680

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 Hydrochloride 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

Medique Medi Meclizine Label

Medique®

Medi-Meclizine

All Day Relief

Alivio que Perdura Todo el Dia

Pull to Open

Tire Para Abrir

For the Prevention and Treatment of Motion Sickness • Meclizine HCl 25mg

Para la Prevencion y el Tratamiento del Mareo “Mal del Viajero” • Hidrochloruro de Meclizina 25mg

100 Tablets

(50 x 2)

Tamper Evident Unit Dose Packets

Empaquetado con Sellado Evidente en Dosis Unitarias


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

  • Do not take more than directed
  • take the first dose ½ hour to 1 hour before starting activity

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

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 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

Inactive ingredients

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

Section 53413-1 (53413-1)

Questions or comments? Call 1-800-634-7680

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 Hydrochloride 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

Medique Medi Meclizine Label (Medique Medi-Meclizine Label)

Medique®

Medi-Meclizine

All Day Relief

Alivio que Perdura Todo el Dia

Pull to Open

Tire Para Abrir

For the Prevention and Treatment of Motion Sickness • Meclizine HCl 25mg

Para la Prevencion y el Tratamiento del Mareo “Mal del Viajero” • Hidrochloruro de Meclizina 25mg

100 Tablets

(50 x 2)

Tamper Evident Unit Dose Packets

Empaquetado con Sellado Evidente en Dosis Unitarias


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)