MECLIZINE HCL- meclizine hydrochloride tablet
Rising Pharma Holdings, 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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Meclizine Hydrochloride Tablets

Drug Facts
Active ingredient (in each tablet)

12.5 mg Tablet: Meclizine HCl 12.5 mg

25 mg Tablet: Meclizine HCl 25 mg

Purpose

Antiemetic

Uses

prevents and treats nausea, vomiting or dizziness associated with motion sickness.

Directions

dosage should be taken one hour before travel starts

for 25 mg: adults and children 12 years and over, take 1 or 2 tablets once daily or directed by a doctor

for 12.5 mg: adults and children 12 years and over, take 2 or 4 tablets once daily or directed by a doctor

Inactive Ingredients

magnesium sterate, microcrystalline cellulose, silicon dioxide, lactose monohydrate

Other Information

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Questions or Comments?

Call 1-844-474-7464

Warnings

Do not use in children under 12 years of age unless directed by a doctor

Do not take this product, unless directed by a doctor, if you have

glaucoma
a breathing problem such as emphysema or chronic bronchitis
trouble urinating due to an enlarged prostate gland

Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor.

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 immediately (1-800-222-1222).

Manufactured by:

Aurex laboratories LLC
East Windsor, NJ 08520

Distributed by:

Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816

Revised:08/2021

Meclizine HCl Tablets

25 mg

100

meclizine-25mg-front

meclizine-25mg-back

Meclizine HCl Tablets

12.5 mg

100

meclizine-12.5mg

meclizine-12.5mg-back

MECLIZINE HCL
meclizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:16571-751
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570)	MECLIZINE HYDROCHLORIDE	12.5 mg

Ingredient Name	Strength
Inactive Ingredients
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	white (White to off white)	Score	2 pieces
Shape	ROUND	Size	8mm
Flavor		Imprint Code	A;C4
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:16571-751-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	08/17/2021	01/31/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part336	08/17/2021	01/31/2023

MECLIZINE HCL
meclizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:16571-752
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	white (White to off white)	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	AM7
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:16571-752-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	08/17/2021	02/28/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part336	08/17/2021	02/28/2023

Labeler - Rising Pharma Holdings, Inc. (116880195)

Registrant - Aurex Laboratories Limited Liability Company (067585317)

Name	Address	ID/FEI	Business Operations
Establishment
Aurex Laboratories Limited Liability Company		067585317	manufacture(16571-751, 16571-752) , pack(16571-751, 16571-752) , analysis(16571-751, 16571-752) , label(16571-751, 16571-752)

Revised: 7/2023

Document Id: 5955ab7d-5927-4092-91ed-fa9b21b86b1a

Set id: 7f375ef7-1bb7-412f-b097-0d350e27dbf8

Version: 2

Effective Time: 20230712

Rising Pharma Holdings, Inc.