Meclizine Hydrochloride by REMEDYREPACK INC. 5172C- Rubgy

Meclizine Hydrochloride by

Drug Labeling and Warnings

Meclizine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by REMEDYREPACK INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MECLIZINE HYDROCHLORIDE- meclizine hydrochloride tablet, chewable 
REMEDYREPACK INC.

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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

DRUG: Meclizine Hydrochloride

GENERIC: Meclizine Hydrochloride

DOSAGE: TABLET, CHEWABLE

ADMINSTRATION: ORAL

NDC: 70518-3015-0

COLOR: pink

FLAVOR: VANILLA

SHAPE: ROUND

SCORE: Two even pieces

SIZE: 9 mm

IMPRINT: 5172

PACKAGING: 10 in 1 BOTTLE, PLASTIC

ACTIVE INGREDIENT(S):

• MECLIZINE HYDROCHLORIDE 25mg in 1

INACTIVE INGREDIENT(S):

• CROSPOVIDONE
• VANILLA
• MAGNESIUM STEARATE
• RASPBERRY
• STEARIC ACID
• SILICON DIOXIDE
• FD&C RED NO. 40
• LACTOSE MONOHYDRATE
• SACCHARIN SODIUM
• CROSCARMELLOSE SODIUM

MECLIZINE HYDROCHLORIDE 
meclizine hydrochloride tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70518-3015(NDC: 0536-1299)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570)	MECLIZINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	pink (Rosy)	Score	2 pieces
Shape	ROUND	Size	9mm
Flavor	VANILLA, RASPBERRY	Imprint Code	5172
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70518-3015-0	10 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/03/2021	04/23/2024
2	NDC: 70518-3015-1	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	02/08/2021	04/23/2024
3	NDC: 70518-3015-2	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	06/03/2021	08/18/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M009	02/03/2021	04/23/2024

Labeler - REMEDYREPACK INC. (829572556)

Revised: 4/2024

Document Id: 16c41acb-933f-05d6-e063-6294a90adcfc

34390-5

Set id: a57b3139-1587-4405-9d04-ebf4eb121b09

Version: 4

Effective Time: 20240423