MECLIZINE HYDROCHLORIDE- meclizine hcl tablet, chewable

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 chewable tablet)

Meclizine HCl 25 mg

Purpose

Antiemetic

Uses

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

Warnings

Do not use

for 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

• alcohol, sedatives, and tranquilizers may increase drowsiness
• drowsiness may occur
• avoid alcoholic beverages 
• 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.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• do not exceed recommended dose
• dosage should be taken one hour before travel starts
• chew or crush tablets completely before swallowing;do not swallow tablets whole
• adults and children 12 years and over: take 1 to 2 tablets once daily or as directed by a doctor

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

corn starch, FD&C red #40 aluminum lake, flavor, lactose anhydrous, magnesium stearate, saccharin sodium, silicon dioxide

Questions or comments?

1-800-540-3765

Principal Display Panel

INGREDIENTS AND APPEARANCE

MECLIZINE HYDROCHLORIDE 
meclizine hcl tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80136-779
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
STARCH, CORN (UNII: O8232NY3SJ)
FD&C RED NO. 40 (UNII: WZB9127XOA)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	pink	Score	2 pieces
Shape	ROUND	Size	9mm
Flavor	RASPBERRY	Imprint Code	44;404
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80136-779-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M009	11/01/2022

Labeler - NORTHEAST PHARMA (081232935)

Registrant - GERI-CARE PHARMACEUTICAL CORP (611196254)