TRAVEL SICKNESS MECLIZINE HCL

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Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each chewable tablet)

Meclizine HCl USP 25 mg

OTC - PURPOSE SECTION

Purpose

Antiemetic

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings

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 it you are taking sedatives or tranquilizers.

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

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.

DOSAGE & ADMINISTRATION SECTION

Directions

• 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 SECTION

Other information

• Phenylketonurics: Contains Phenylalanine 0.28 mg per tablet
• Store at room temperature in a dry place
• Keep lid tightly closed

INACTIVE INGREDIENT SECTION

Inactive ingredients

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.

OTC - QUESTIONS SECTION

Questions or comments?

call 1-800-645-2158

OTHER SAFETY INFORMATION

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

SPL UNCLASSIFIED SECTION

Distributed by: Rugby Laboratories

17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50436-3989

NDC: 50436-3989-1 30 TABLET, CHEWABLE in a BOTTLE

RUGBY TRAVEL SICKNESS MECLIZINE HCL, 25 MG EACH (ANTIEMETIC) (MECLIZINE HCL) TABLET, CHEWABLE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

• TRAVEL SICKNESS MECLIZINE HCL
• Meclizine HCl
• ASPARTAME
• CROSCARMELLOSE SODIUM
• DEXTROSE, UNSPECIFIED FORM
• FD&C RED NO. 40
• MAGNESIUM STEARATE
• MALTODEXTRIN
• MICROCRYSTALLINE CELLULOSE
• SILICON DIOXIDE
• SODIUM SULFATE
• SUCROSE
• TRICALCIUM PHOSPHATE
• MECLIZINE HYDROCHLORIDE
• MECLIZINE

NDC Codes#

Ingredients#

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

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

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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 · 1 matching rows.

Reported adverse events (FAERS/openFDA)#

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