FDA.reportPublic FDA data

Meclizine HCL 12.5 mg

Manufacturer
RPK Pharmaceuticals, Inc.
Effective date
2020-12-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:01:22

Label at a glance#

ProductMeclizine HCL 12.5 mg
Active ingredientMECLIZINE HYDROCHLORIDE
Label structure17 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

Active indredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Meclizine HCL 12.5 mg

Purpose

OTC - PURPOSE SECTION

Antiemetic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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.

OTC - ASK DOCTOR 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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

SPL UNCLASSIFIED SECTION

  • each caplet contains: calcium 51 mg
  • store at room temperature 15º-30ºC (59º-86ºF)
  • This is a bulk package. Dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

SPL UNCLASSIFIED SECTION

Distributed by: Reliable 1 Laboratoires LLC, Valley Stream, NY 11580

www.reliable1labs.com

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 53002-6060

NDC: 53002-6060-1 10 TABLET in a BOTTLE

NDC: 53002-6060-2 20 TABLET in a BOTTLE

NDC: 53002-6060-3 30 TABLET in a BOTTLE

Meclizine HCl 12.5mg Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-6060-12024-06-11C16284748780-19d75b9cf-f128-f424-e053-dadaa90a57ceMeclizine HCL 12.5
53002-6060-22024-06-11C16284748780-19d75b9cf-f128-f424-e053-dadaa90a57ceMeclizine HCL 12.5
53002-6060-32024-06-11C16284748780-19d75b9cf-f128-f424-e053-dadaa90a57ceMeclizine HCL 12.5
53002-6060-12023-01-30C16284748780-19d75b9cf-f128-f424-e053-dadaa90a57ceMeclizine HCL 12.5
53002-6060-22023-01-30C16284748780-19d75b9cf-f128-f424-e053-dadaa90a57ceMeclizine HCL 12.5
53002-6060-32023-01-30C16284748780-19d75b9cf-f128-f424-e053-dadaa90a57ceMeclizine HCL 12.5
53002-6060-12020-12-17C16284748780-19d75b9cf-f128-f424-e053-dadaa90a57ceMeclizine HCL 12.5
53002-6060-22020-12-17C16284748780-19d75b9cf-f128-f424-e053-dadaa90a57ceMeclizine HCL 12.5
53002-6060-32020-12-17C16284748780-19d75b9cf-f128-f424-e053-dadaa90a57ceMeclizine HCL 12.5
53002-6060-12020-01-31C16284748780-19d75b9cf-f128-f424-e053-dadaa90a57ceMeclizine HCL 12.5
53002-6060-22020-01-31C16284748780-19d75b9cf-f128-f424-e053-dadaa90a57ceMeclizine HCL 12.5
53002-6060-32020-01-31C16284748780-19d75b9cf-f128-f424-e053-dadaa90a57ceMeclizine HCL 12.5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69618-027-01EA - Each69618-027e78a02a0-6dfa-432d-8cbc-ddf3e88d963712016-05-16
69618-027-10EA - Each69618-0277ce7769a-4a4f-4fab-a44b-6e35d580602312016-05-16

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53002-606053002-6060-3, 53002-6060-1, 53002-6060-2
69618-027

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
MECLIZINE HYDROCHLORIDEHDP7W44CIOACTIB
MAGNESIUM STEARATE70097M6I30IACT
STEARIC ACID4ELV7Z65APIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meclizine HCL 12.5 mgMECLIZINE HCL 12.5 MGReliable 1 Laboratories LLC32832b0f-0b38-27ce-e054-00144ff8d46c2025-01-15WarningsExact identifier
ndc (product): 69618-027
ef55ea07-d997-4282-8e95-40fd06502e3eb442caed-926b-4331-92b8-cefc967f21ac2024-06-10WarningsExact identifier
spl set id: b442caed-926b-4331-92b8-cefc967f21ac

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.