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Meclizine HCl by Rugby Laboratories Inc.

Medically reviewed on December 11, 2017

Dosage form: tablet
Ingredients: MECLIZINE HYDROCHLORIDE 12.5mg
Labeler: Rugby Laboratories Inc.
NDC Code: 0536-3985

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.

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

1000 caplets

NDC 0536-3985-01

Rugby

Meclizine HCl 12.5 mg Caplets USP
Antiemetic

100 caplets

MECLIZINE HCL 
meclizine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-3985
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MECLIZINE HYDROCHLORIDE (MECLIZINE) MECLIZINE HYDROCHLORIDE12.5 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
STEARIC ACID 
SILICON DIOXIDE 
Product Characteristics
ColorWHITEScore2 pieces
ShapeCAPSULESize13mm
FlavorImprint CodeAP;117
Contains    
Packaging
#Item CodePackage Description
1NDC:0536-3985-101000 TABLET (TABLET) in 1 BOTTLE
2NDC:0536-3985-01100 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33607/14/2006
Labeler - Rugby Laboratories Inc. (191427277)
Registrant - Advance Pharmaceutical Inc. (078301063)
Establishment
NameAddressID/FEIOperations
Advance Pharmaceutical Inc.078301063MANUFACTURE(0536-3985)

 
Rugby Laboratories Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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