Your browser does not support JavaScript! VERTICALM (MECLIZINE HYDROCHLORIDE) TABLET [ALVA-AMCO PHARMACAL COMPANIES, INC.]
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VERTICALM (meclizine hydrochloride) tablet
[Alva-Amco Pharmacal Companies, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Label Sections

Active ingredient (in each tablet)

Meclizine hydrochloride, 25 mg

Purpose

Anti-emetic

Uses

For the prevention and treatment of

  • nausea
  • vomiting
  • dizziness associated with motion sickness

Warnings


Do not use

  • in children under 12 years of age unless directed by a doctor.

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers

When using this product

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

If pregnant or breastfeeding, 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

  • Read all package directions and warnings before use.
  • Use only as directed.
  • Adults: Swallow one (1) or two (2) tablets with water once daily or as directed by a doctor.
  • For use by normally healthy adults only.
  • Persons under 18 years of age should use only as directed by a doctor.
  • If you experience continuous or recurring symptoms, check with your doctor for appropriate diagnosis and treatment.

Other information

  • **Contents sealed: Each Verticalm yellow, round shaped tablet bears the identfying mark "ALVA", and is sealed in a clear plastic blister with a foil backing.
  • Do not use if seal appears broken or if product contents do not match product description.
  • You may report serious side effects to the phone number provided under Questions? below.

Inactive ingredients

Corn starch, croscarmellose sodium, D&C Yellow No. 10 Lake, lactose, magnesium stearate, microcrystalline cellulose, silica, stearic acid.

Questions?  1-800-792-2582

Verticalm PDP

VERTICALM 
meclizine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:52389-623
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MECLIZINE HYDROCHLORIDE (MECLIZINE) MECLIZINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
CROSCARMELLOSE SODIUM 
D&C YELLOW NO. 10 
Lactose 
Magnesium stearate 
CELLULOSE, MICROCRYSTALLINE 
Silicon dioxide 
Stearic acid 
Product Characteristics
Coloryellow (yellow) Scoreno score
ShapeROUNDSize9mm
FlavorImprint Code ALVA
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52389-623-241 in 1 CARTON
124 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33604/16/2012
Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)

Revised: 4/2012
 
Alva-Amco Pharmacal Companies, Inc.

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