MECLIZINE HYDROCHLORIDE tablet, chewable

United States - English - NLM (National Library of Medicine)

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Active ingredient:
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570)
Available from:
Rugby Laboratories
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose Antiemetic prevents and treats nausea, vomiting or dizziness due to motion sickness
Authorization status:
OTC monograph final
Authorization number:
0536-1299-01, 0536-1299-10

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MECLIZINE HYDROCHLORIDE- meclizine hydrochloride tablet, chewable

Rugby Laboratories

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®.

Distributed by:

RUGBY® LABORATORIES

17177 N Laurel Park Dr., Suite 233

Livonia, MI 48152

www.rugbylaboratories.com

Rugby

NDC 0536-1299-10

Compare to the active ingredient in Bonine®*

Meclizibe 25 mg

Antiemetic

1000 Chewable Tablets

MECLIZINE HYDROCHLORIDE

meclizine hydrochloride tablet, chewable

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 536 -129 9

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

MECLIZINE HYDRO CHLO RIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ8 4570 )

MECLIZINE HYDROCHLORIDE 25 mg

Inactive Ingredients

Ingredient Name

Stre ng th

CRO SPO VIDO NE (UNII: 2S78 30 E56 1)

VANILLA (UNII: Q74T350 78 H)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

RASPBERRY (UNII: 4N14V5R27W)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

LACTO SE MO NO HYDRATE (UNII: EWQ57Q8 I5X)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

Product Characteristics

Color

pink (Ro sy)

S core

2 pieces

S hap e

ROUND

S iz e

9 mm

Flavor

VANILLA, RASPBERRY

Imprint Code

5172

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 536 -129 9 -0 1

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

10 /30 /20 20

2

NDC:0 536 -129 9 -10

10 0 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

11/0 9 /20 20

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt336

10 /30 /20 20

Labeler -

Rugby Laboratories (079246066)

Rugby Laboratories

Revised: 12/2020

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