Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 9377d7c1-23da-404a-9676-f50e148d9521
Route
ORAL
Published
Effective Date 2010-03-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Meclizine (25 mg)
Inactive Ingredients
Silicon Dioxide Fd&c Red No. 40 Lactose Crospovidone Croscarmellose Sodium Raspberry Vanilla Saccharin Sodium Magnesium Stearate Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: BMS Shape: round Color: pink Size: 9 mm Score: 2
Marketing Status
OTC MONOGRAPH FINAL Active Since 2009-03-16

Description

Meclizine Hydrochloride 25 mg

Purpose

Antiemetic


Medication Information

Purpose

Antiemetic

Description

Meclizine Hydrochloride 25 mg

Uses

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

Warnings

Do not take this product if you have asthma, glaucoma, emphysema, chronic pulmonary disease, shortness of breath, difficulty in breathing, or difficulty in urination due to enlargement of the prostate gland, unless directed by a physician. Do not give to children under 12 years of age unless directed by a physician. May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your physician. Use caution when driving a motor vehicle or operating machinery. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

Directions

Adult oral dosage is one to two tablets once daily or as directed by a physician.

Active Ingredient

Meclizine Hydrochloride 25 mg

Inactive Ingredients

Crosscarmellose Sodium, Crospovidone, FD&C Red #40 Lake, Lactose, Magnesium Stearate, Raspberry Flavor, Silica, Sodium Saccharin, Stearic Acid and Vanilla Flavor.

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Structured Label Content

Uses

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

Purpose

Antiemetic

Warnings

Do not take this product if you have asthma, glaucoma, emphysema, chronic pulmonary disease, shortness of breath, difficulty in breathing, or difficulty in urination due to enlargement of the prostate gland, unless directed by a physician. Do not give to children under 12 years of age unless directed by a physician. May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your physician. Use caution when driving a motor vehicle or operating machinery. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

Directions

Adult oral dosage is one to two tablets once daily or as directed by a physician.

Active Ingredient (Active ingredient)

Meclizine Hydrochloride 25 mg

Inactive Ingredients (Inactive ingredients)

Crosscarmellose Sodium, Crospovidone, FD&C Red #40 Lake, Lactose, Magnesium Stearate, Raspberry Flavor, Silica, Sodium Saccharin, Stearic Acid and Vanilla Flavor.

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Advanced Ingredient Data


Raw Label Data

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