MECLIZINE HYDROCHLORIDE- meclizine hydrochloride tablet
Sandoz Inc

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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Drug Facts

Active ingredient

Meclizine hydrochloride, USP 12.5 mg

Meclizine hydrochloride, USP 25 mg

Purpose

Antiemetic

Uses

For prevention and treatment of these symptoms associated with motion sickness

•: nausea
•: vomiting
•: dizziness

Warnings

Ask a doctor before use if you have

•: a breathing problem such as emphysema or chronic bronchitis
•: glaucoma
•: difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

•: giving this product to children under 12 years of age
•: taking sedatives or tranquilizers

When using this product

•: you may get drowsy
•: alcohol, sedatives, and tranquilizers may increase drowsiness
•: avoid alcoholic drinks
•: be careful 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

•: take first dose one hour before starting activity
•: adults and children (12 years and over) 25 to 50 mg (2 to 4 tablets) once daily or as directed by a doctor
•: not more than 4 tablets in 24 hours

Other Information

•: Safety sealed: do not use if the imprinted bottle seal is open or torn.
•: Keep tightly closed

•: Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature).

Inactive ingredients

Croscarmellose sodium, FD&C blue #1 aluminum lake, hydroxypropyl methylcellulose, lactose (monohydrate), magnesium stearate, microcrystalline cellulose and polysorbate 80

Questions or comments?

1-800-525-8747

Sandoz Inc.

Princeton, NJ 08540

10-2008M

12.5 mg Label

NDC 0781-1345-01

Meclizine HCl

Tablets, USP

12.5 mg

Antiemetic

Relief of:

Nausea Vomiting Dizziness

100 Tablets

SANDOZ

25 mg Label

NDC 0781-1375-01

Meclizine HCl

Tablets, USP

25 mg

Antiemetic

Relief of:

Nausea Vomiting Dizziness

100 Tablets

SANDOZ

MECLIZINE HYDROCHLORIDE
meclizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0781-1345
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570)	MECLIZINE HYDROCHLORIDE	12.5 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	BLUE	Score	score with uneven pieces
Shape	OVAL	Size	5mm
Flavor		Imprint Code	GG;141
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0781-1345-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/22/1998	02/02/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part336	05/22/1989	02/02/2015

MECLIZINE HYDROCHLORIDE
meclizine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0781-1375
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570)	MECLIZINE HYDROCHLORIDE	25 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Characteristics
Color	YELLOW	Score	score with uneven pieces
Shape	OVAL	Size	6mm
Flavor		Imprint Code	GG;261
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0781-1375-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/22/1989	09/02/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part336	05/22/1989	02/02/2015

Labeler - Sandoz Inc (110342024)

Revised: 2/2019

Document Id: 27ad9197-a9d2-4c29-8b6f-e62de870cb24

Set id: 9250c587-1a02-418b-9f3f-31e9fe00fc5f

Version: 11

Effective Time: 20190211

Sandoz Inc