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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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

C:\Users\advance\Desktop\word docs - rugby\Meclizine 25 mg 100-1000 ct\Figure 3.png

COMPARE TO ACTIVE INGREDIENT IN BONINE

Meclizine HCl 25 mg (ANTIEMETIC)

NDC 0536-3990-10

1000 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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
ASPARTAME (UNII: Z0H242BBR1)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SUCROSE (UNII: C151H8M554)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
RASPBERRY (UNII: 4N14V5R27W)  
Product Characteristics
ColorREDScore2 pieces
ShapeROUNDSize8mm
FlavorRASPBERRYImprint Code AP;115
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-3990-101000 in 1 BOTTLE; Type 0: Not a Combination Product07/22/200803/31/2018
2NDC:0536-3990-01100 in 1 BOTTLE; Type 0: Not a Combination Product07/22/200807/29/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33607/22/200807/29/2018
Labeler - Rugby Laboratories Inc. (079246066)

Revised: 12/2019
 
Rugby Laboratories Inc.