Meclizine HCl Caplets USP

Meclizine HCl by

Drug Labeling and Warnings

Meclizine HCl by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories Inc., Advance Pharmaceutical Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MECLIZINE HCL- meclizine hcl tablet 
Rugby Laboratories Inc.

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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Meclizine HCl Caplets USP

Active Ingredient

(in each caplet)

Meclizine HCl 12.5 mg USP

Purpose

Antiemetic

Uses

prevents and treats nausea, vomiting, or dizziness due to motion sickness

WARNINGS

Ask a doctor before use if you have

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

  • you may get drowsy
  • avoid alcoholic drinks
  • alcohol, sedatives & tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating a machinery
  •   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 over: 2-4 caplets once daily
  • children under 12 years: ask a doctor

Other Information

  • each caplet contains: calcium 51 mg
  • store at room temperature 15°-30°C (59°-86°F)

Inactive Ingredients

croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

Questions or Comments

Call 1-800-645-2158, 9 am – 5 pm ET, Monday - Friday

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR BLISTER UNIT IS BROKEN OR DAMAGED

Rugby® Duluth, Georgia 30097

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 0536-3985-10

Rugby

Meclizine HCl 12.5 mg Caplets USP
Antiemetic

100 caplets

bottle label
MECLIZINE HCL 
meclizine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0536-3985
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE12.5 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorWHITEScore2 pieces
ShapeCAPSULESize13mm
FlavorImprint Code AP;117
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0536-3985-101000 in 1 BOTTLE; Type 0: Not a Combination Product07/14/200603/18/2015
2NDC: 0536-3985-01100 in 1 BOTTLE; Type 0: Not a Combination Product07/14/200601/29/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33607/14/200601/29/2016
Labeler - Rugby Laboratories Inc. (079246066)
Registrant - Advance Pharmaceutical Inc. (078301063)

Revised: 12/2019
Document Id: b71c9252-71ec-4c7c-a25d-b7b60d83b244
Set id: d226fd69-fb4a-49e0-9933-85284cb01cb6
Version: 3
Effective Time: 20191219
 
Rugby Laboratories Inc.