Meclizine Tablet
FDA Label NDC 80513-427

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Advanced Rx Llc for the product Meclizine (NDC 80513-427). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each caplet), purpose, uses, warnings, when using this product, if pregnant or breast-feeding,, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Caplet)

Meclizine HCl 12.5mg

Purpose

Antiemetic

Uses

prevents and treats nausea, vomiting or dizziness associated with motion sickness

Warnings

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

Do not take unless directed by a doctor if you have

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

    • Do not take if you aretaking sedatives or tranquilizers, without first consulting your doctor.

When Using This Product

  • do not exceed recommended dosage
  • drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • 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 (1-800-222-1222).

Directions

  • dosage should be taken 1 hour before travel starts 
    • adults and children 12 years and over

    take 2 or 4 caplets once daily or as directed by a doctor

Other Information

  • Tamper Evident: do not use if safety seal under cap is broken or missing
  • each caplet contains: calcium 28 mg
  • store at room temperature 20°-25°C (68°-77°F).

Inactive Ingredients

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

Questions Or Comments?

call 1-800-630-8895, 8:30 am - 4:30 pm ET, Monday-Friday

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