MECLIZINE HYDROCHLORIDE- meclizine hydrochloride tablet, chewable 
REMEDYREPACK 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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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

 Each tablet contains 0.09 mg of Magnesium and 0.82 mg of Sodium

 store at room temperature in a dry place

 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

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

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

*This product is not manufactured or distributed by Prestige Brands, Inc owner of the registered trademark Bonine®.

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

DRUG: Meclizine Hydrochloride

GENERIC: Meclizine Hydrochloride

DOSAGE: TABLET, CHEWABLE

ADMINSTRATION: ORAL

NDC: 70518-3015-0

NDC: 70518-3015-1

NDC: 70518-3015-2

COLOR: pink

FLAVOR: VANILLA

SHAPE: ROUND

SCORE: Two even pieces

SIZE: 9 mm

IMPRINT: 5172

PACKAGING: 10 in 1 BOTTLE, PLASTIC

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

INACTIVE INGREDIENT(S):

Remedy_Label

MM2

MM3

MECLIZINE HYDROCHLORIDE 
meclizine hydrochloride tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-3015(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)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
Colorpink (Rosy) Score2 pieces
ShapeROUNDSize9mm
FlavorVANILLA, RASPBERRYImprint Code 5172
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70518-3015-010 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/03/2021
2NDC:70518-3015-130 in 1 BLISTER PACK; Type 0: Not a Combination Product02/08/2021
3NDC:70518-3015-230 in 1 BLISTER PACK; Type 0: Not a Combination Product06/03/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33602/03/2021
Labeler - REMEDYREPACK INC. (829572556)

Revised: 6/2021
Document Id: c3e00e18-22fc-72f0-e053-2a95a90ab052
Set id: a57b3139-1587-4405-9d04-ebf4eb121b09
Version: 3
Effective Time: 20210603
 
REMEDYREPACK INC.