Meclizine HCl 25 mg Chewable Tablets

Manufacturer
NuCare Pharmceuticals,Inc. | NuCare Pharmaceuticals,Inc.
Effective date
2021-02-23
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 22:50:13

Label at a glance#

ProductMeclizine HCl 25 mg
Active ingredientMECLIZINE HYDROCHLORIDE
Label structure16 sections

Indications and uses

prevents and treats nausea, vomiting or dizziness due to motion sickness

Dosage and administration

Dosage should be taken one hour before travel starts. Adults and children 12 years of age and older: Chew 1-2 tablets once daily or as directed by a doctor Children under 12 years: do not give this product to children under 12 years of age unless directed by a doctor.

Storage and handling

store at room temperature

Label contents#

Full prescribing information#

Active ingredient (in each chewable tablet)

OTC - ACTIVE INGREDIENT SECTION

Meclizine HCl, USP 25 mg

Purpose

OTC - PURPOSE SECTION

Antiemetic

Uses

INDICATIONS & USAGE SECTION

prevents and treats nausea, vomiting or dizziness due to motion sickness

OTC - DO NOT USE SECTION

Do not use in children under 12 years of age unless directed by a doctor.

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 - 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 the poison control center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Dosage should be taken one hour before travel starts.
  • Adults and children 12 years of age and older: Chew 1-2 tablets once daily or as directed by a doctor
  • Children under 12 years: do not give this product to children under 12 years of age unless directed by a doctor.

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature

OTHER SAFETY INFORMATION

  • Phenylketonurics: Contains phenylalanine 0.28 mg per tablet
  • Do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

aspartame, croscarmellose sodium, dextrose, FD&C Red #40 Lake, magnesium stearate, maltodextrin, microcrystalline cellulose, natural and artificial flavors, silicon dioxide, sodium sulfate, sugar, tricalcium phosphate.

Questions or comments?

OTC - QUESTIONS SECTION

If you have any questions or comments or to report an adverse event, please contact (800) 795-9775.

SPL UNCLASSIFIED SECTION

Distributed by: Plus Pharma, Commack, NY 11725

*Plus Pharma is not affiliated with the owner of the registered trademark Bonine®.

OTC - WHEN USING SECTION

When using this product

  • may cause drowsiness
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • use caution when driving a motor vehicle or operating machinery

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdppdp

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2178-22024-07-17C16284748780-1ba0f9c33-1066-a910-e053-dadaa90a0b85Meclizine HCl 25 mg Chewable Tablets
68071-2178-32024-07-17C16284748780-1ba0f9c33-1066-a910-e053-dadaa90a0b85Meclizine HCl 25 mg Chewable Tablets
68071-2178-42024-07-17C16284748780-1ba0f9c33-1066-a910-e053-dadaa90a0b85Meclizine HCl 25 mg Chewable Tablets
68071-2178-62024-07-17C16284748780-1ba0f9c33-1066-a910-e053-dadaa90a0b85Meclizine HCl 25 mg Chewable Tablets
68071-2178-22023-01-30C16284748780-1ba0f9c33-1066-a910-e053-dadaa90a0b85Meclizine HCl 25 mg Chewable Tablets
68071-2178-32023-01-30C16284748780-1ba0f9c33-1066-a910-e053-dadaa90a0b85Meclizine HCl 25 mg Chewable Tablets
68071-2178-42023-01-30C16284748780-1ba0f9c33-1066-a910-e053-dadaa90a0b85Meclizine HCl 25 mg Chewable Tablets
68071-2178-62023-01-30C16284748780-1ba0f9c33-1066-a910-e053-dadaa90a0b85Meclizine HCl 25 mg Chewable Tablets
68071-2178-22021-02-23C16284748780-1ba0f9c33-1066-a910-e053-dadaa90a0b85Meclizine HCl 25 mg Chewable Tablets
68071-2178-32021-02-23C16284748780-1ba0f9c33-1066-a910-e053-dadaa90a0b85Meclizine HCl 25 mg Chewable Tablets
68071-2178-42021-02-23C16284748780-1ba0f9c33-1066-a910-e053-dadaa90a0b85Meclizine HCl 25 mg Chewable Tablets
68071-2178-62021-02-23C16284748780-1ba0f9c33-1066-a910-e053-dadaa90a0b85Meclizine HCl 25 mg Chewable Tablets
68071-2178-22021-01-29C16284748780-1ba0f9c33-1066-a910-e053-dadaa90a0b85Meclizine HCl 25 mg Chewable Tablets
68071-2178-32021-01-29C16284748780-1ba0f9c33-1066-a910-e053-dadaa90a0b85Meclizine HCl 25 mg Chewable Tablets
68071-2178-42021-01-29C16284748780-1ba0f9c33-1066-a910-e053-dadaa90a0b85Meclizine HCl 25 mg Chewable Tablets
68071-2178-62021-01-29C16284748780-1ba0f9c33-1066-a910-e053-dadaa90a0b85Meclizine HCl 25 mg Chewable Tablets

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51645-994-01EA - Each51645-994094ec1d6-7d2f-47b2-bfba-42e4d43dd5be12016-03-04
51645-994-10EA - Each51645-9941e7b29ee-6984-4e20-aacf-83d5b646caee12016-03-04

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68071-217868071-2178-2, 68071-2178-3, 68071-2178-4, 68071-2178-6
51645-994

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML · Source PDF

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1d75906d-238a-f76c-e063-6294a90ac9636f9010fe-e033-22cc-e053-2a91aa0a361e2024-07-17WarningsExact identifier
spl set id: 6f9010fe-e033-22cc-e053-2a91aa0a361e

Reported adverse events (FAERS/openFDA)#

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