Hpc 778l (378)

Hpc 778l (378)
SPL v2
SPL
SPL Set ID e3c73fdc-670d-118f-e053-2a95a90a954c
Route
ORAL
Published
Effective Date 2013-12-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: 44;403 Shape: round Color: yellow Size: 9 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-05-01

Description

Meclizine HCI 25mg

Purpose

Antiemetic


Medication Information

Purpose

Antiemetic

Description

Meclizine HCI 25mg

Uses

For the prevention and treatment of these symptoms associated with motion sickness • nausea • vomiting • dizziness

Section 50565-1

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

Warnings

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

Ask a doctor before use if you have

• breathing problems, such as emphysema or chronic bronchitis

• glaucoma

• difficulty urinating due to an enlarged prostate gland

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

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

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



Directions
  • take the first dose 1/2 hour to 1 hour before starting activity
  • Adults and children 12 years of age and over:

Take 1 to 2 tablets once daily, or as directed by a doctor

Do not exceed 2 tablets in 24 hours.

Package Label

Other Information

TAMPER EVIDENT:Do not use if imprinted seal under cap is broken or missing.

• store at 20-25ºC (68-77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

• protect from humidity

Inactive Ingredients

colloidal silicon dioxide, D&C yellow #10 lake, lactose monohydrate, magnesium stearate, pregelatinized starch.

Questions Or Comments?

1-800-540-3765

Active Ingredient (in Each Tablet)

Meclizine HCI 25mg


Structured Label Content

Uses

For the prevention and treatment of these symptoms associated with motion sickness • nausea • vomiting • dizziness

Section 50565-1 (50565-1)

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

Purpose

Antiemetic

Warnings

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

Ask a doctor before use if you have

• breathing problems, such as emphysema or chronic bronchitis

• glaucoma

• difficulty urinating due to an enlarged prostate gland

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

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

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



Directions
  • take the first dose 1/2 hour to 1 hour before starting activity
  • Adults and children 12 years of age and over:

Take 1 to 2 tablets once daily, or as directed by a doctor

Do not exceed 2 tablets in 24 hours.

Package Label (package label)

Other Information (Other information)

TAMPER EVIDENT:Do not use if imprinted seal under cap is broken or missing.

• store at 20-25ºC (68-77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

• protect from humidity

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, D&C yellow #10 lake, lactose monohydrate, magnesium stearate, pregelatinized starch.

Questions Or Comments? (Questions or comments?)

1-800-540-3765

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Meclizine HCI 25mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)