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Meclizine HCl by Rugby Laboratories Inc.

Dosage form: tablet
Ingredients: MECLIZINE HYDROCHLORIDE 25mg
Labeler: Rugby Laboratories Inc.
NDC Code: 0536-3990

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.

Travel Sickness

Active Ingredient

(in each tablet)

Meclizine HCl 25 mg 

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 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
  • take dose one hour before travel starts
  • tablets can be chewed or swallowed whole with water
  • adults & children 12 years and over: 1-2 tablets once daily

    children under 12 years: ask a doctor

Other Information
  • phenylketonurics: each tablet contains: phenylalanine 0.28mg
  • store at room temperature 15°-30°C (59°-86°F)

Inactive Ingredients

aspartame, compressible sugar, croscarmellose sodium, dextrose, FD&C red # 40(Al-lake), magnesium stearate, microcrystalline cellulose, raspberry flavor

Questions or Comments

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

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Rugby® Duluth, Georgia 30097

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Meclizine HCl

COMPARE TO ACTIVE INGREDIENT IN BONINE

Meclizine HCl 25 mg (ANTIEMETIC)

NDC 0536-3990-10

1000 CHEWABLE TABLETS

Contains Aspartame

Rugby

Duluth, Georgia 30097

COMPARE TO ACTIVE INGREDIENT IN BONINE

Meclizine HCl 25 mg (ANTIEMETIC)

NDC 0536-3990-01

100 CHEWABLE TABLETS

Contains Aspartame

Rugby

Duluth, Georgia 30097

MECLIZINE HCL 
meclizine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-3990
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MECLIZINE HYDROCHLORIDE (MECLIZINE) MECLIZINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
ASPARTAME 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SUCROSE 
DEXTROSE 
FD&C RED NO. 40 
RASPBERRY 
Product Characteristics
ColorREDScore2 pieces
ShapeROUNDSize8mm
FlavorRASPBERRYImprint CodeAP;115
Contains    
Packaging
#Item CodePackage Description
1NDC:0536-3990-101000 TABLET (TABLET) in 1 BOTTLE
2NDC:0536-3990-01100 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33607/22/2008
Labeler - Rugby Laboratories Inc. (191427277)
Registrant - Advance Pharmaceutical Inc. (078301063)
Establishment
NameAddressID/FEIOperations
Advance Pharmaceutical Inc.078301063MANUFACTURE(0536-3990)

 
Rugby Laboratories Inc.

← See all Meclizine HCl brands

Medically reviewed on Dec 10, 2018

Further information

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

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