MECLIZINE HYDROCHLORIDE- meclizine hcl tablet 
NORTHEAST PHARMA

----------

hpc 778L (378)

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 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

1

MECLIZINE HYDROCHLORIDE 
meclizine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80136-378
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
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
ColoryellowScoreno score
ShapeROUNDSize9mm
FlavorImprint Code 44;403
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80136-378-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00905/01/2022
Labeler - NORTHEAST PHARMA (081232935)
Registrant - Geri-Care Pharmaceutical Corp (611196254)

Revised: 11/2023
Document Id: 0a20bfde-2901-285a-e063-6394a90a02b8
Set id: e3c73fdc-670d-118f-e053-2a95a90a954c
Version: 2
Effective Time: 20231114
 
NORTHEAST PHARMA