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. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (in each tablet)

Meclizine HCL 25 mg

PURPOSE

Purpose

Antiemetic

INDICATIONS & USAGE

Uses

For the prevention and treatment of these symptoms associated with motion sickness nausea vomiting dizziness

WARNINGS

Warnings

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

Ask a doctor before use if you have

glaucoma

breathing problems, such as emphysema or chronic bronchitis

difficulty urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product

drowsiness may occur

avoid alcoholic beverages

alcohol, sedatives and tranquilizers may increase drowsiness

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.

DOSAGE & ADMINISTRATION

Directions

• to prevent motion sickness, take the first dose one hour before starting activity
• not for frequent or prolonged use except on the advice of a doctor
• do not exceed recommended dose

Adults and children 12 years of age and older: Take 1-2 tablets once daily, or as directed by a doctor. Do not exceed 2 tablets in 24 hours.

STORAGE AND HANDLING

Other information

• store at room temperature 15˚-30˚C (59˚-86˚F)
• protect from humidity

INACTIVE INGREDIENT

Inactive ingredients: D&C yellow # 10 lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, colloidal silicon dioxide.

QUESTIONS

Questions or Comments?

Call 1-855-642-2594

BOXED WARNING

(What is this?)

Tamper evident:Do not use if safety seal is broken or missing

SPL UNCLASSIFIED SECTION

Comapre to active ingredient in DRAMAMINE ® ALL DAY LESS DROWSY*

*This product is not manufactured or distributed by the owner of registered trademark of DRAMAMINE ®

MADE IN USA

Manufactured by:

APNAR PHARMA LLP

East Windsor, NJ 08520

Rev.:10/2022

PRINCIPAL DISPLAY PANEL

NDC: 24689-146-01

Meclizine HCL 25 mg

Antiemetic

100 Tablets

INGREDIENTS AND APPEARANCE

MECLIZINE HYDROCHLORIDE 
meclizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24689-146
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)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	AM4
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24689-146-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	11/21/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M009	11/21/2022

Labeler - APNAR PHARMA LP (079568229)

Establishment
Name	Address	ID/FEI	Business Operations
APNAR PHARMA LLP		118530917	manufacture(24689-146) , analysis(24689-146) , pack(24689-146)