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NDC 17714-0117-01 Meclizine HCL 12.5 mg 12.5 mg/1 Details

Meclizine HCL 12.5 mg 12.5 mg/1

Meclizine HCL 12.5 mg is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Advance Pharmaceutical Inc.. The primary component is MECLIZINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Meclizine is used to prevent and treat nausea, vomiting, and dizziness caused by motion sickness. It is most effective if taken before symptoms appear.

Related Packages: 17714-0117-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Meclizine

Product Information

NDC	17714-0117
Product ID	17714-117_5cc9755e-6d41-fa9f-e053-2991aa0afbef
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Meclizine HCL 12.5 mg
Proprietary Name Suffix	n/a
Non-Proprietary Name	Meclizine HCL 12.5 mg
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	12.5
Active Ingredient Units	mg/1
Substance Name	MECLIZINE HYDROCHLORIDE
Labeler Name	Advance Pharmaceutical Inc.
Pharmaceutical Class	Antiemetic [EPC], Emesis Suppression [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part336
Listing Certified Through	2024-12-31

Package

Package Images

NDC 17714-0117-01 (17714011701)

Pricing Information	N/A
NDC Package Code	17714-117-01
Billing NDC	17714011701
Package	100 TABLET in 1 BOTTLE (17714-117-01)
Marketing Start Date	2013-07-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 76efad7e-e765-430f-9232-63553d02f2c5 Details

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.

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

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
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

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

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

Labeler - Advance Pharmaceutical Inc. (078301063)

Registrant - Advance Pharmaceutical Inc. (078301063)

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

Revised: 10/2017

Document Id: 5cc9755e-6d41-fa9f-e053-2991aa0afbef

Set id: 76efad7e-e765-430f-9232-63553d02f2c5

Version: 2

Effective Time: 20171030

Search by Drug Name or NDC

NDC 17714-0117-01 Meclizine HCL 12.5 mg 12.5 mg/1 Details

Meclizine HCL 12.5 mg 12.5 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 17714-0117-01 (17714011701)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 76efad7e-e765-430f-9232-63553d02f2c5 Details

Drug Facts

Active indredient (in each caplet)

Purpose

Uses

Warnings

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Directions

Other information

Inactive ingredients

Questions or comments?

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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