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

Meclizine Hydrochloride 12.5 mg Label

25 mg Label

NDC 0781-1375-01

Meclizine HCl

Tablets, USP

25 mg

Antiemetic

Relief of:

Nausea Vomiting Dizziness

100 Tablets

SANDOZ

Meclizine Hydrochloride 25 mg Label
MECLIZINE HYDROCHLORIDE 
meclizine hydrochloride tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0781-1345
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MECLIZINE HYDROCHLORIDE (UNII: HDP7W44CIO) (MECLIZINE - UNII:3L5TQ84570) MECLIZINE HYDROCHLORIDE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
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     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0781-1345-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/22/1998 02/02/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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
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
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     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0781-1375-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/22/1989 09/02/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part336 05/22/1989 02/02/2015
Labeler - Sandoz Inc (110342024)

Revised: 2/2019
Sandoz Inc