MECLIZINE HCL- meclizine hydrochloride tablet

Meclizine HCl by

Drug Labeling and Warnings

Meclizine HCl by is a Otc medication manufactured, distributed, or labeled by Drug Ocean LLC, Unique Pharmaceutical Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients (in each tablet)

Meclizine HCl, USP 12.5 mg

Purpose

Antiemetic

Uses:

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

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.

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

ASK DOCTOR/PHARMACIST

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

When using 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.

In case of overdose, get medical help or contact a Poison Control Center right away

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

Call 1-844-200-6566 Monday to Friday 9 AM to 5 PM EST

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF FOIL SEAL UNDER CAP, PRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING

Distributed by:
Drug Ocean LLC,
1 Bridge Plaza, North Central Road,

6th Floor, Suite 675,

Fort Lee, NJ 07024

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

ORG 12/23

PRINCIPAL DISPLAY PANEL - 12.5 mg Tablet Label

NDC: 70985-009-01

Meclizine HCl

12.5 mg

100 Tablets

Distributed by:

Drug Ocean LLC,

1 Bridge Plaza, North Central Road,

6th Floor, Suite 675
Fort Lee, NJ 07024

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

ORG 12/23

INGREDIENTS AND APPEARANCE

MECLIZINE HCL 
meclizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70985-009
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: 70985-009-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	06/25/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M009	06/25/2021

Labeler - Drug Ocean LLC (080381835)

Registrant - Drug Ocean LLC (080381835)

Establishment
Name	Address	ID/FEI	Business Operations
Unique Pharmaceutical Laboratories		650434645	manufacture(70985-009)