MECLIZINE HYDROCHLORIDE- meclizine hydrochloride tablet, chewable 
Pharmasource Meds, LLC

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 Chewable Tablets

Drug Facts

Active ingredient (in each chewable tablet)
Meclizine HCl 25 mg

Purpose

Antiemetic

Uses

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

Do not use in

children under 12 years of age unless directed by a doctor

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

 Do not exceed recommended dosage

 may cause drowsiness

 alcohol, sedatives, and tranquilizers may increase drowsiness

 avoid alcoholic drinks
 use caution 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 (1-800-222-1222).

Directions

 Dosage should be taken one hour before travel starts

adults and children 12
years of age and over
chew 1 to 2 tablets once daily, or as directed by a doctor
children under
12 years of age
do not give this product to children under 12 years of age
unless directed by a doctor

Other information

 Store in a dry place at 15°-30°C (59°-86°F)
 keep lid tightly closed

Croscarmellose Sodium, Crospovidone, FD&C Red #40 Lake, French Vanilla Flavor, Lactose, Magnesium Stearate, Raspberry Flavor, Silica, Sodium Saccharin, Stearic Acid

Questions or comments?

1-800-645-2158

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

*This product is not manufactured or distributed by Wellspring Pharmaceutical Corporation, owner of the registered trademark Bonine®.

Distributed by:

RUGBY® LABORATORIES

Indianapolis, IN 46268

Please reference the "Other information" section listed above for storage information. This drug product has been received by Pharmasource Meds, LLC in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable GMP regulations. The drug product is repackaged and labeled for single patient use to be dispensed within a pharmacy setting as a single patient prescription.


www.rugbylaboratories.com

Repackaged by:
Pharmasource Meds, LLC
Tigard, OR 97223

NDC: 82982-036-30
Meclizine USP
Chewable Tablets
25 mg

Repackaged for RxOnly settings
30 Chewable Tablets
Pharmasource Meds, LLC

meclizine label

MECLIZINE HYDROCHLORIDE 
meclizine hydrochloride tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82982-036(NDC:0536-1299)
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
CROSPOVIDONE (UNII: 2S7830E561)  
VANILLA (UNII: Q74T35078H)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
RASPBERRY (UNII: 4N14V5R27W)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
Product Characteristics
Colorpink (Rosy) Score2 pieces
ShapeROUNDSize9mm
FlavorVANILLA, RASPBERRYImprint Code 5172
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82982-036-3030 in 1 BOTTLE; Type 0: Not a Combination Product04/14/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM00904/14/2023
Labeler - Pharmasource Meds, LLC (118772692)

Revised: 4/2023
Document Id: f956fc32-0e88-39bf-e053-6394a90a1574
Set id: f9568e8c-4ba1-b37b-e053-6294a90a0240
Version: 2
Effective Time: 20230414
 
Pharmasource Meds, LLC