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

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.

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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

Container Label for SEA-CALM Packet - 2 Tablets

SEA-CALM 
meclizine hcl 25mg chewable tablets tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59961-123
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorPINKScore2 pieces
ShapeROUNDSize9mm
FlavorFRUITImprint Code BMS
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59961-123-012 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/FEIBusiness Operations
Contract Pharmacal Corporation057795122MANUFACTURE

Revised: 3/2010
Document Id: 9377d7c1-23da-404a-9676-f50e148d9521
Set id: 9377d7c1-23da-404a-9676-f50e148d9521
Version: 1
Effective Time: 20100309
 
Bellegrove