Medi-First/Medi-First Plus PMS Relief

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each caplet)

Acetaminophen 500 mg

Pamabrom 25 mg

Pyrilamine maleate 15 mg

OTC - PURPOSE SECTION

Purpose

Pain reliever

Diuretic

Antihistamine

INDICATIONS & USAGE SECTION

Uses

for the temporary relief of these symptoms associated with menstrual periods:

■ headache

■ bloating

■ cramps

■ backache

■ muscular aches

■ irritability

■ water-weight gain

WARNINGS SECTION

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

■ more than 4,000 mg of acetaminophen in 24 hours

■ with other drugs containing acetaminophen

■ 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

■ skin reddening

■ blisters

■ rash

If a skin reaction occurs, stop use and seek medical help right away.

OTC - DO NOT USE SECTION

Do not use

■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

■ if you have ever had an allergic reaction to this product or any of its ingredients

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

■ difficulty in urination due to enlargement of the prostate gland

■ a breathing problem such as emphysema or chronic bronchitis

■ liver disease

■ glaucoma

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

■ taking sedatives or tranquilizers

■ taking the blood thinning drug warfarin

OTC - WHEN USING SECTION

When using this product

■ drowsiness may occur

■ avoid alcoholic beverages

■ excitability may occur, especially in children

■ alcohol, sedatives and tranquilizers may increase drowsiness

■ use caution when driving a motor vehicle or operating machinery

OTC - STOP USE SECTION

Stop use and ask a doctor if

■ pain gets worse or lasts more than 10 days

■ fever gets worse or lasts more than 3 days

■ new symptoms occur

■ redness or swelling is present

These could be signs of a serious condition.

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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION SECTION

Directions

■ do not take more than directed

Adults and children: (12 years and over)

■ take 2 caplets with water every 6 hours as needed

■ do not exceed 6 caplets in a 24 hour period or as directed by a doctor

Children under 12 years: ask a doctor

OTHER SAFETY INFORMATION

Other information

■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

■ tamper-evident sealed packets

■ do not use any opened or torn packets

INACTIVE INGREDIENT SECTION

Inactive ingredients

corn starch, croscarmellose sodium, crospovidone, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, shellac wax, silicon dioxide, stearic acid, talc, titanium dioxide

OTC - QUESTIONS SECTION

Questions or comments? 1-800-634-7680

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Medi-First®

PMS Relief

Pain Reliever • Acetaminophen 500 mg

Diuretic • Pamabrom 25 mg

Antihistamine • Pyrilamine maleate 15 mg

Mestrual Pain Relief

Pull to Open

This Package is for Households Without Young Children.

Tamper Evident Unit Dose Packets

80 Caplets

(40 x 2)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Medi-First®Plus