MECLIZINE HCL- meclizine hcl 25mg chewable tablets tablet, chewable 
Aphena Pharma Solutions - Tennessee, 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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Motion Sickness

Active ingredient

Meclizine Hydrochloride 25 mg

Purpose

Antiemetic

Uses

For the prevention and treatment of nausea, vomiting or dizziness associated with motion sickness. For other uses consult your doctor

Warnings

Ask a doctor before use if you have

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

When using this product

Directions

take dose one hour before travel starts
tablets can be chewed or swallowed whole with water

adults & children 12 years and over:

children under 12 years:

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

OTHER INFORMATION

Phenylketonurics:
each tablet contains:
phenylalanine 0.28 mg
store at room temparature 15 - 30 °C

Questions or Comments

Call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive ingredients

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

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count25 mg
3071610-0528-30
9071610-0528-60

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:
Aphena Pharma Solutions - TN
Cookeville, TN 38506

20210415JH

PRINCIPAL DISPLAY PANEL - 25 mg

NDC 71610-528 - Meclizine HCl 25 mg Chewable Tablets
Bottle Label 25 mg

MECLIZINE HCL 
meclizine hcl 25mg chewable tablets tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71610-528(NDC:54738-025)
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
ASPARTAME (UNII: Z0H242BBR1)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
DEXTROSE (UNII: IY9XDZ35W2)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
RASPBERRY (UNII: 4N14V5R27W)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorredScore2 pieces
ShapeROUNDSize8mm
FlavorRASPBERRYImprint Code AP;115
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71610-528-3030 in 1 BOTTLE; Type 0: Not a Combination Product03/04/2021
2NDC:71610-528-6090 in 1 BOTTLE; Type 0: Not a Combination Product03/04/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33605/01/2015
Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)
Establishment
NameAddressID/FEIBusiness Operations
Aphena Pharma Solutions - Tennessee, LLC128385585REPACK(71610-528)

Revised: 4/2021
Document Id: ce757363-1c5a-476b-b373-dd5e7097d56a
Set id: 02d1af4d-d97d-4019-a5bf-3ec391238676
Version: 1
Effective Time: 20210415
 
Aphena Pharma Solutions - Tennessee, LLC