MECLIZINE HCL- meclizine hcl 25mg chewable tablets tablet, chewable

Meclizine HCL by

Drug Labeling and Warnings

Meclizine HCL by is a Otc medication manufactured, distributed, or labeled by Richmond Pharmaceuticals, Inc., Advance Pharmaceutical Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Meclizine Hydrochloride 25 mg

Purpose

Antiemetic

Uses

For the prevention and treatment of nausea, vomiting or dizziness associated with motion sickness. For other uses consult your doctor

Warnings

Ask a doctor before use if you have

• glaucoma
• a breathing problem such as emphysema or chronic bronchitis
• trouble urinating due to an elarged prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

• you may get drowsy
• avoid alcoholic drinks
• alcohol, sedatives and tranquilizers may increse drowsiness
• be careful when driving a moor vehicle or operating machinery

Directions

take dose one hour before travel starts
tablets can be chewed or swallowed whole with water

adults & children 12 years and over:

• take 1-2 tablets once daily

children under 12 years:

• ask a doctor

Keep out of reach of children.

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

OTHER INFORMATION

Phenylketonurics:
each tablet contains:
phenylalanine 0.28 mg
store at room temparature 15 - 30 °C

Questions or Comments

Call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive ingredients

Aspartame, compressible sugar, croscarmellose sodium, dextrose, FD&C red 40 (al-lake), magnesium stearate, microcrystalline cellulose, raspberry flavor

Package/Label Principal Display Panel

NDC :  54738-025-01- 100 CHEW TABS

NDC : 54738-025-03- 1000 CHEW TABS

INGREDIENTS AND APPEARANCE

MECLIZINE HCL 
meclizine hcl 25mg chewable tablets tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54738-025
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
ASPARTAME (UNII: Z0H242BBR1)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DEXTROSE (UNII: IY9XDZ35W2)
FD&C RED NO. 40 (UNII: WZB9127XOA)
RASPBERRY (UNII: 4N14V5R27W)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	red	Score	2 pieces
Shape	ROUND	Size	8mm
Flavor	RASPBERRY	Imprint Code	AP;115
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54738-025-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2015
2	NDC: 54738-025-03	1000 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part336	05/01/2015

Labeler - Richmond Pharmaceuticals, Inc. (043569607)

Registrant - Advance Pharmaceutical Inc. (078301063)

Establishment
Name	Address	ID/FEI	Business Operations
Advance Pharmaceutical Inc.		078301063	manufacture(54738-025)