MECLIZINE HCL 12.5 MG tablet

Meclizine HCL 12.5 mg by

Drug Labeling and Warnings

Meclizine HCL 12.5 mg by is a Otc medication manufactured, distributed, or labeled by Advance Pharmaceutical Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active indredient (in each caplet)

Meclizine HCL 12.5 mg

Purpose

Antiemetic

Uses

• prevents and treats nausea, vomiting, or dizziness due to motion sickness
• for other uses, consult your doctor

Warnings

Ask a docotor before use if you have

• glaucoma
• a breathing problem such as emphysema or chronic bronchitis
• trouble 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

• you may get drowsy
• avoid alcoholic drinks
• alcohol, sedatives and tranquillizers may increase drowsiness
• 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.

ASK DOCTOR

Ask a doctor before use if you have

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

WHEN USING

When using this prodcut

• you may get drowsy
• avoid alcoholic drinks
• alcohol, sedatives and tranqulizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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

Directions

• adults & children 12 years and over: 2-4 caplets once daily
• children under 12 years: ask a doctor

Other information

• each caplet contains: calcium 51 mg
• store at room temperature 15º-30ºC (59º-86ºF)

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

Questions or comments?

call 631-981-4600, 8.30 am-4.30 pm ET, Monday - Friday
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

PRINCIPAL DISPLAY PANEL

NDC: 17714-117-01

Meclizine 12.5mg caplets

INGREDIENTS AND APPEARANCE

MECLIZINE HCL 12.5 MG 
meclizine hcl 12.5 mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17714-117
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STEARIC ACID (UNII: 4ELV7Z65AP)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)

Product Characteristics
Color	white	Score	2 pieces
Shape	OVAL	Size	13mm
Flavor		Imprint Code	AP;117
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17714-117-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part336	07/01/2013

Labeler - Advance Pharmaceutical Inc. (078301063)

Registrant - Advance Pharmaceutical Inc. (078301063)

Establishment
Name	Address	ID/FEI	Business Operations
Advance Pharmaceutical Inc.		078301063	manufacture(17714-117)