SEA-CALM- meclizine hcl 25mg chewable tablets tablet, chewable

SEA-CALM by

Drug Labeling and Warnings

SEA-CALM by is a Otc medication manufactured, distributed, or labeled by Bellegrove, Contract Pharmacal Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Meclizine Hydrochloride 25 mg

Purpose

Antiemetic

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

INGREDIENTS AND APPEARANCE

SEA-CALM 
meclizine hcl 25mg chewable tablets tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59961-123
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570)	MECLIZINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FD&C RED NO. 40 (UNII: WZB9127XOA)
LACTOSE (UNII: J2B2A4N98G)
CROSPOVIDONE (UNII: 68401960MK)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
RASPBERRY (UNII: 4N14V5R27W)
VANILLA (UNII: Q74T35078H)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	PINK	Score	2 pieces
Shape	ROUND	Size	9mm
Flavor	FRUIT	Imprint Code	BMS
Contains

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
OTC monograph final	part336	03/16/2009

Labeler - Bellegrove (070966486)

Registrant - Contract Pharmacal Corporation (057795122)

Establishment
Name	Address	ID/FEI	Business Operations
Contract Pharmacal Corporation		057795122	MANUFACTURE