MECLIZINE HYDROCHLORIDE tablet

Meclizine Hydrochloride by

Drug Labeling and Warnings

Meclizine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by APNAR PHARMA LP, APNAR PHARMA LLP, INVAHEALTH INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient (in each tablet)

12.5mg tablet: Meclizine HCL.... 12.5 mg

25mg tablet : Meclizine HCL .....25 mg

PURPOSE

Purpose

Antiemetic

INDICATIONS & USAGE

Uses

Prevents and treats nausea, vomiting or dizziness associated with motion sickness

DOSAGE & ADMINISTRATION

Directions

Meclizine HCL 12.5mg tablet :

Dosage should be taken one hour before travel starts -adults & children 12 years and over: take 2 or 4 tablets once daily or as directed by a doctor

Meclizine HCL 25mg tablet:

Dosage should be taken one hour before travel starts -adults & children 12 years and over: take 1 or 2 tablets once daily or as directed by a doctor

INACTIVE INGREDIENT

Inactive Ingredients

Magnesium stearate, microcrystalline cellulose,silicon dioxide, lactose monohydrate

STORAGE AND HANDLING

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]

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 urination 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

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)

QUESTIONS

Questions or Comments?

Call 1-855-642-2594

SPL UNCLASSIFIED SECTION

Rev.: 05/2022

Made in USA

Manufactured by:

APNAR PHARMA LLP

East Windsor, NJ 08520

BOXED WARNING

(What is this?)

TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING

PRINCIPAL DISPLAY PANEL

NDC : 24689-138-01

Meclizine Hydrochloride Tablets 12.5 mg

Antiemetic

100 Tablets

NDC : 24689-139-01

Meclizine Hydrochloride Tablets 25 mg

Antiemetic

100 Tablets

INGREDIENTS AND APPEARANCE

MECLIZINE HYDROCHLORIDE 
meclizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24689-138
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
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND	Size	7mm
Flavor		Imprint Code	A;C4
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24689-138-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	07/29/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M009	07/29/2022

MECLIZINE HYDROCHLORIDE 
meclizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24689-139
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)

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: 24689-139-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	07/29/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M009	07/29/2022

Labeler - APNAR PHARMA LP (079568229)

Establishment
Name	Address	ID/FEI	Business Operations
APNAR PHARMA LLP		118530917	manufacture(24689-138, 24689-139) , analysis(24689-138, 24689-139) , pack(24689-138, 24689-139)

Establishment
Name	Address	ID/FEI	Business Operations
INVAHEALTH INC		116840615	label(24689-138, 24689-139) , pack(24689-138, 24689-139)