TRAVEL SICKNESS CHEWABLE TABLETS

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

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:Cookeville, TN 3850620190314JH