Tension Headache Relief

Drug Facts

SPL UNCLASSIFIED SECTION

Active Ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg Caffeine 65 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever Pain reliever aid

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches and pains due to: • headache • muscular aches

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: • more than 6 tablets in 24 hours, which is the maximum daily amount • 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. Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine- containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

Do not use

OTC - DO NOT USE SECTION

• if you are allergic to acetaminophen • with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

liver disease

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin

Stop use and ask a doctor if

OTC - STOP USE SECTION

• any new symptoms occur • painful area is red or swollen • pain gets worse or lasts for more than 10 days • fever gets worse or lasts for more than 3 days. These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• do not use more than directed • adults and children 12 years and over; take 2 tablets every 6 hours; not more than 6 tablets in 24 hours • children under 12 years: ask a doctor

Other Information

STORAGE AND HANDLING SECTION

• Store at 20°–25°C (68°–77°F) • close cap tightly after use • read all product information before using

Inactive ingredients

INACTIVE INGREDIENT SECTION

Colloidal silicon dioxide, croscarmellose sodium, D&C Red No. 27, FD&C Blue No. 2, FD&C Yellow No. 6, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, purified water, stearic acid, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-888-333-9792

Distributed by:

SPL UNCLASSIFIED SECTION

Cabinet Health P.B.C.

Pouch

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL