MECLIZINE HYDROCHLORIDE- meclizine hcl tablet

Meclizine Hydrochloride by

Drug Labeling and Warnings

Meclizine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by NORTHEAST PHARMA, Geri-Care Pharmaceutical Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Meclizine HCI 25mg

Purpose

Antiemetic

Uses

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

Warnings

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

Ask a doctor before use if you have

breathing problems, such as emphysema or chronic bronchitis

glaucoma

difficulty urinating due to an enlarged prostate gland

A sk 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
I f 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

• take the first dose 1/2 hour to 1 hour before starting activity
• Adults and children 12 years of age and over:

Take 1 to 2 tablets once daily, or as directed by a doctor
Do not exceed 2 tablets in 24 hours.

Other information

TAMPER EVIDENT:Do not use if imprinted seal under cap is broken or missing.

store at 20-25ºC (68-77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

protect from humidity

Inactive ingredients

colloidal silicon dioxide, D&C yellow #10 lake, lactose monohydrate, magnesium stearate, pregelatinized starch.

Questions or comments?

1-800-540-3765

package label

INGREDIENTS AND APPEARANCE

MECLIZINE HYDROCHLORIDE 
meclizine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80136-378
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)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
MAGNESIUM STEARATE (UNII: 70097M6I30)
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	44;403
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80136-378-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M009	05/01/2022

Labeler - NORTHEAST PHARMA (081232935)

Registrant - Geri-Care Pharmaceutical Corp (611196254)