Meclizine Hcl 12.5 Mg Tablet
FDA Label NDC 71205-762

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Proficient Rx Lp for the product Meclizine Hcl 12.5 Mg (NDC 71205-762). 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, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, otc - pregnancy or breast feeding, 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)

→ Purpose

→ Uses

→ Warnings

→ Otc - Ask Doctor

→ Otc - Ask Doctor/pharmacist

→ Otc - When Using

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Other

→ Package Label.principal Display Panel

Active Ingredient (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 tranquilizers 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

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

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

Otc - When Using

When using this product

you may get drowsy
avoid alcoholic drinks
alcohol, sedatives and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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 15°-30°C (59°-86°F)
This is a bulk package. Dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.