MECLIZINE HYDROCHLORIDE tablet, chewable

Meclizine Hydrochloride by

Drug Labeling and Warnings

Meclizine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by A-S Medication Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each chewable tablet)
Meclizine HCl 25 mg

PURPOSE

Purpose

Antiemetic

Uses

prevents and treats nausea, vomiting or dizziness due to motion sickness

WARNINGS

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

INACTIVE INGREDIENT

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

SPL UNCLASSIFIED SECTION

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

HOW SUPPLIED

Product: 50090-5496

NDC: 50090-5496-0 30 TABLET, CHEWABLE in a BOTTLE

MECLIZINE HYDROCHLORIDE

INGREDIENTS AND APPEARANCE

MECLIZINE HYDROCHLORIDE 
meclizine hydrochloride tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50090-5496(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, UNSPECIFIED (UNII: 2S7830E561)
VANILLA BEAN (UNII: Q74T35078H)
MAGNESIUM STEARATE (UNII: 70097M6I30)
RASPBERRY (UNII: 4N14V5R27W)
STEARIC ACID (UNII: 4ELV7Z65AP)
SILICA (UNII: ETJ7Z6XBU4)
FD&C RED NO. 40 (UNII: WZB9127XOA)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
SODIUM SACCHARIN (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: 50090-5496-0	30 in 1 BOTTLE; Type 0: Not a Combination Product	03/19/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M009	10/30/2020

Labeler - A-S Medication Solutions (830016429)

Establishment
Name	Address	ID/FEI	Business Operations
A-S Medication Solutions		830016429	RELABEL(50090-5496) , REPACK(50090-5496)