MECLIZINE HCL- meclizine hydrochloride tablet

Meclizine HCl by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts Active ingredient (in each tablet)

Meclizine HCl, USP 12.5 mg

Purpose

Antiemetic

Uses

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

Warnings

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

WARNINGS

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

WARNINGS

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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 and over: take 2 or 4 tablets once daily or as directed by a doctor

Other information

• store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Inactive ingredients

colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose

Questions or comments?

Call 1-844-474-7464 Monday to Friday 8 AM - 5 PM ET

Manufactured by:
Unique Pharmaceutical Laboratories
(A Div. of J.B.Chemicals &
Pharmaceuticals Ltd.),
Mumbai 400 030, India

Mfg. Lic. No.: G/1430

Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816

Issued: 02/2024

138528

PRINCIPAL DISPLAY PANEL - 12.5 mg tablets container label

NDC: 57237-333-01

Meclizine Hydrochloride Tablets, USP

12.5 mg

100 Tablets

INGREDIENTS AND APPEARANCE

MECLIZINE HCL 
meclizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57237-333
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSPOVIDONE (UNII: 2S7830E561)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	white (White to Off White)	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	AB;12
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57237-333-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	07/22/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M009.50	07/22/2024

Labeler - Rising Pharma Holdings, Inc. (116880195)

Registrant - Unique Pharmaceutical Laboratories (917165052)

Establishment
Name	Address	ID/FEI	Business Operations
Unique Pharmaceutical Laboratories		650434645	manufacture(57237-333)