Meclizine HCl by NORTHEAST PHARMA / Geri-Care Pharmaceutical Corp HPC 778

Meclizine HCl by

Drug Labeling and Warnings

Meclizine HCl 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]

MECLIZINE HCL- meclizine hcl tablet 
NORTHEAST PHARMA

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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HPC 778

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

• to prevent motion sickness, take the first

dose 1/2 to 1 hour before starting activity

• not for frequent or prolonged use except on the advice of a doctor
• Adults and children 12 years of age and over: Take 1-2
  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 room temperature 15˚-30˚C (59˚-86˚F)

protect from humidity

Inactive ingredients

D&C yellow #10 lake,
lactose, magnesium stearate, microcrystalline
cellulose, silica, sodium starch glycolate, starch.

package label

MECLIZINE HCL 
meclizine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80136-778
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
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
MAGNESIUM STEARATE (UNII: 70097M6I30)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	TCL086
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80136-778-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part336	09/01/2020	09/01/2020

Labeler - NORTHEAST PHARMA (081232935)

Registrant - Geri-Care Pharmaceutical Corp (611196254)

Revised: 12/2021

Document Id: d22f3949-61a8-d705-e053-2a95a90a0447

34390-5

Set id: b622b39e-99ad-3cbc-e053-2995a90a22b6

Version: 2

Effective Time: 20211202