MECLIZINE HYDROCHLORIDE- meclizine hydrochloride tablet, chewable 
Aphena Pharma Solutions - Tennessee, LLC

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5172C- Rubgy

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
www.rugbylaboratories.com

REPACKAGING INFORMATION

Please reference the HOW SUPPLIED section listed above for a description of individual drug products listed below. This drug product has been received by Aphena Pharma Solutions - Tennessee, LLC 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:

25mg
NDC 71610-836-30, Bottles of 30 Tablets
NDC 71610-836-53, Bottles of 60 Tablets
NDC 71610-836-60, Bottles of 90 Tablets
NDC 71610-836-80, Bottles of 180 Tablets



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
Cookeville, TN 38506

20240529AMH

PRINCIPAL DISPLAY PANEL - 25mg

NDC 71610-836 - Meclizine 25mg Tablets - Rx Only

Label

MECLIZINE HYDROCHLORIDE 
meclizine hydrochloride tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71610-836(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:71610-836-3030 in 1 BOTTLE; Type 0: Not a Combination Product05/24/2024
2NDC:71610-836-5360 in 1 BOTTLE; Type 0: Not a Combination Product05/24/2024
3NDC:71610-836-6090 in 1 BOTTLE; Type 0: Not a Combination Product05/24/2024
4NDC:71610-836-80180 in 1 BOTTLE; Type 0: Not a Combination Product05/24/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00910/30/2020
Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)
Establishment
NameAddressID/FEIBusiness Operations
Aphena Pharma Solutions - Tennessee, LLC 128385585repack(71610-836)

Revised: 6/2024
Document Id: 1a8bdae4-1b42-0a1c-e063-6294a90a49aa
Set id: 199ae195-4556-ee88-e063-6394a90a40d4
Version: 2
Effective Time: 20240610
 
Aphena Pharma Solutions - Tennessee, LLC