MEDIQUE MEDI-MECLIZINE- meclizine hydrochloride tablet 
A-S Medication Solutions

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 (in each tablet)

Meclizine Hydrochloride 25 mg

Purpose

Antiemetic

Uses

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

Warnings

Do not use

  • for children under 12 years of age unless directed by a doctor
  • for frequent or prolonged use except under the advice of a doctor

Ask a doctor before use if you have

  • breathing problems such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland

if you are

  • taking sedatives or tranquilizers

When using this product

  • drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase the drowsiness effect
  • avoid alcoholic beverages while taking this product
  • use caution when driving a motor vehicle or operating machinery

Do not exceed recommended dosage.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Adults and children: (12 years and older) 1 to 2 tablets once daily or as directed by a doctor. Do not exceed 2 tablets in 24 hours.

Children under 12 years: Do not give to children under 12 years of age.

Other information

Inactive ingredients

anhydrous lactose, colloidal silicon dioxide, corn starch, D&C yellow # 10, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions or comments?

1-800-634-7680

HOW SUPPLIED

Product: 50090-4493

NDC: 50090-4493-0 2 TABLET in a PACKET / 500 in a BOX

MECLIZINE HYDROCHLORIDE

Label Image
MEDIQUE MEDI-MECLIZINE 
meclizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-4493(NDC:47682-480)
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
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
Coloryellow (yellow) Score2 pieces
ShapeROUND (ROUND) Size9mm
FlavorImprint Code TCL;086
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50090-4493-0500 in 1 BOX08/30/2019
12 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33609/01/2013
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIBusiness Operations
A-S Medication Solutions830016429RELABEL(50090-4493)

Revised: 4/2021
Document Id: 81f218cb-345b-4f3f-8aff-bdc40d0bc9a3
Set id: d7419e82-55d7-4699-a2d5-c45c54f845c7
Version: 3
Effective Time: 20210415
 
A-S Medication Solutions