SEA-CALM

Dosage form: tablet, chewable
Ingredients: MECLIZINE HYDROCHLORIDE 25mg
Labeler: Bellegrove
NDC Code: 59961-123

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

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

SEA-CALM 
meclizine hcl 25mg chewable tablets tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59961-123
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MECLIZINE HYDROCHLORIDE (MECLIZINE) MECLIZINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
FD&C RED NO. 40 
LACTOSE 
CROSPOVIDONE 
CROSCARMELLOSE SODIUM 
RASPBERRY 
VANILLA 
SACCHARIN SODIUM 
MAGNESIUM STEARATE 
STEARIC ACID 
Product Characteristics
ColorPINKScore2 pieces
ShapeROUNDSize9mm
FlavorFRUITImprint CodeBMS
Contains    
Packaging
#Item CodePackage Description
1NDC:59961-123-012 TABLET, CHEWABLE (TABLET) in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33603/16/2009
Labeler - Bellegrove (070966486)
Registrant - Contract Pharmacal Corporation (057795122)
Establishment
NameAddressID/FEIOperations
Contract Pharmacal Corporation057795122MANUFACTURE

Revised: 03/2010
 
Bellegrove

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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