MECLIZINE HYDROCHLORIDE tablet, chewable

Meclizine Hydrochloride by

Drug Labeling and Warnings

Meclizine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Aphena Pharma Solutions - Tennessee, LLC. 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

 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

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

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

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN 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:

• Count: 25 mg
• 30: 71610-526-30
• 90: 71610-526-60

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:

Cookeville, TN 38506

20210318JH

PRINCIPAL DISPLAY PANEL - 25 mg

NDC: 71610-526 - Meclizine HCl 25 mg Tablets

INGREDIENTS AND APPEARANCE

MECLIZINE HYDROCHLORIDE 
meclizine hydrochloride tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71610-526(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)
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
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: 71610-526-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	02/09/2021
2	NDC: 71610-526-60	90 in 1 BOTTLE; Type 0: Not a Combination Product	02/09/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part336	10/30/2020

Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)

Establishment
Name	Address	ID/FEI	Business Operations
Aphena Pharma Solutions - Tennessee, LLC		128385585	REPACK(71610-526)