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SEA-CALM

Bellegrove
Contract Pharmacal Corporation

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Meclizine Hydrochloride 25 mg

Purpose

Antiemetic

SEA-CALM 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.

Inactive ingredients

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

Package/Label Principal Display Panel

SEA-CALM

SEA-CALM

Meclizine HCl 25mg Chewable Tablets TABLET, CHEWABLE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:59961-123
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
MECLIZINE HYDROCHLORIDE MECLIZINE 25 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
FD&C RED NO. 40
LACTOSE
CROSPOVIDONE
CROSCARMELLOSE SODIUM
RASPBERRY
VANILLA
saccharin sodium
MAGNESIUM STEARATE
STEARIC ACID

Product Characteristics

Color Size Imprint Code Shape
PINK 9 mm BMS ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:59961-123-01 2 in 1 PACKET

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part336 2009-03-16


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Be sure to consult your doctor before taking any medication!
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