SPL v4
SPL
SPL Set ID 505f6036-d216-4455-e054-00144ff88e88
Route
ORAL
Published
Effective Date 2015-10-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Meclizine (25 mg)
Inactive Ingredients
Croscarmellose Sodium Fd&c Red No. 40 Cellulose, Microcrystalline Tricalcium Phosphate Aspartame Sucrose Dextrose Magnesium Stearate Maltodextrin Silicon Dioxide Sodium Sulfate

Identifiers & Packaging

Pill Appearance
Imprint: 21G Shape: round Color: pink Size: 8 mm Score: 2
Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-10-15

Description

Meclizine HCl, USP 25 mg

Purpose

Antiemetic


Medication Information

Purpose

Antiemetic

Description

Meclizine HCl, USP 25 mg

Uses

prevents and treats nausea, vomiting or dizziness due to motion sickness

Warnings

WARNINGS

Ask Doctor

Ask a doctor before use if you have

glaucoma

a breathing problem such as emphysema or chronic bronchitis

trouble urinating due to an enlarged prostate gland

Directions

Dosage should be taken one hour before travel starts.

Adults and children 12 years of age and older: Chew 1-2 tablets once daily or as directed by a doctor

Children under 12 years: do not give this product to children under 12 years of age unless directed by a doctor.

Do Not Use

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

When Using

When using this product

may cause drowsiness

alcohol, sedatives, and tranquilizers may increase drowsiness

avoid alcoholic drinks

use caution when driving a motor vehicle or operating machinery

Other Information

store at room temperature

Inactive Ingredients

aspartame, croscarmellose sodium, dextrose, FD&C Red #40 Lake, magnesium stearate, maltodextrin, microcrystalline cellulose, natural and artificial flavors, silicon dioxide, sodium sulfate, sugar, tricalcium phosphate.

Ask Doctor/pharmacist

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

Questions Or Comments?

If you have any questions or comments or to report an adverse event, please contact (800) 795-9775.

Principal Display Panel

Other Safety Information

Phenylketonurics: Contains phenylalanine 0.28 mg per tablet

Do not use if imprinted safety seal under cap is broken or missing

Pregnancy Or Breast Feeding

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

Keep Out of Reach of Children

Keep out of reach of children.

In case of overdose, get medical help or contact the poison control center immediately.

Active Ingredient (in Each Chewable Tablet)

Meclizine HCl, USP 25 mg


Structured Label Content

Uses (USES)

prevents and treats nausea, vomiting or dizziness due to motion sickness

Purpose (PURPOSE)

Antiemetic

Warnings (WARNINGS)

WARNINGS

Ask Doctor (ASK DOCTOR)

Ask a doctor before use if you have

glaucoma

a breathing problem such as emphysema or chronic bronchitis

trouble urinating due to an enlarged prostate gland

Directions (DIRECTIONS)

Dosage should be taken one hour before travel starts.

Adults and children 12 years of age and older: Chew 1-2 tablets once daily or as directed by a doctor

Children under 12 years: do not give this product to children under 12 years of age unless directed by a doctor.

Do Not Use (DO NOT USE)

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

When Using (WHEN USING)

When using this product

may cause drowsiness

alcohol, sedatives, and tranquilizers may increase drowsiness

avoid alcoholic drinks

use caution when driving a motor vehicle or operating machinery

Other Information (OTHER INFORMATION)

store at room temperature

Inactive Ingredients (INACTIVE INGREDIENTS)

aspartame, croscarmellose sodium, dextrose, FD&C Red #40 Lake, magnesium stearate, maltodextrin, microcrystalline cellulose, natural and artificial flavors, silicon dioxide, sodium sulfate, sugar, tricalcium phosphate.

Ask Doctor/pharmacist (ASK DOCTOR/PHARMACIST)

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

Questions Or Comments? (QUESTIONS OR COMMENTS?)

If you have any questions or comments or to report an adverse event, please contact (800) 795-9775.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Other Safety Information (OTHER SAFETY INFORMATION)

Phenylketonurics: Contains phenylalanine 0.28 mg per tablet

Do not use if imprinted safety seal under cap is broken or missing

Pregnancy Or Breast Feeding (PREGNANCY OR BREAST FEEDING)

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

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

Keep out of reach of children.

In case of overdose, get medical help or contact the poison control center immediately.

Active Ingredient (in Each Chewable Tablet) (ACTIVE INGREDIENT (IN EACH CHEWABLE TABLET))

Meclizine HCl, USP 25 mg


Advanced Ingredient Data


Raw Label Data

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