Meclizine Hydrochloride Tablets

Meclizine HCl by

Drug Labeling and Warnings

Meclizine HCl by is a Otc medication manufactured, distributed, or labeled by Rising Pharma Holdings, Inc., Aurex Laboratories Limited Liability Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 HCl Tablets

12.5 mg

100

MECLIZINE HCL 
meclizine hydrochloride tablet

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

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

Inactive Ingredients
Ingredient Name	Strength
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

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

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
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

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

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

Labeler - Rising Pharma Holdings, Inc. (116880195)

Registrant - Aurex Laboratories Limited Liability Company (067585317)

Establishment
Name	Address	ID/FEI	Business Operations
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

34390-5

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

Version: 2

Effective Time: 20230712