Motion Sickness Relief Tablet
FDA Label NDC 83324-032

14 label sections · Submitted to the FDA by Chain Drug Marketing Association, Inc. · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association, Inc. for the product Motion Sickness Relief (NDC 83324-032). 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 tablet), purpose, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, if pregnant 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 Tablet)

→ Purpose

→ Uses

→ Do Not Use

→ Ask A Doctor Before Use If You Have

→ Ask A Doctor Or Pharmacist Before Use If You Are

→ When Using This Product

→ If Pregnant Or Breast-feeding,

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel

Active Ingredient (In Each Tablet)

Dimenhydrinate 50 mg

Purpose

Antiemetic

Uses

for prevention and treatment of these symptoms associated with motion sickness:

nausea
vomiting
dizziness

Do Not Use

for children under 2 years of age unless directed by a doctor.

Ask A Doctor Before Use If You Have

glaucoma
a breathing problem such as emphysema or chronic bronchitis
difficulty in urination due to enlargement of the prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.

When Using This Product

marked drowsiness may occur
alcohol, sedatives, and tranquilizers may increase drowsiness
avoid alcoholic beverages
use caution 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.

Directions

do not take more than directed
to prevent motion sickness, the first dose should be taken one-half to one hour before starting activity
to prevent or treat motion sickness, see below:

adults and children 12 years and over	■ take 1 to 2 tablets every 4-6 hours ■ do not take more than 8 tablets in 24 hours, or as directed by a doctor
children 6 to under 12 years	■ give 1/2 to 1 tablet every 6-8 hours ■ do not give more than 3 tablets in 24 hours, or as directed by a doctor
children 2 to under 6 years	■ give 1/2 tablet every 6-8 hours ■ do not give more than 1 1/2 tablets in 24 hours, or as directed by a doctor

Other Information

each tablet contains: calcium 35 mg
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
protect from moisture
see end flap for expiration date and lot number