Unishield Pain & Ache
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each caplet)
Aspirin 500 mg (NSAID)*
Caffeine 32.5 mg
*nonsteroidal anti-inflammatory drug
OTC - PURPOSE SECTION
Purpose
Pain reliever
Pain reliever aid
INDICATIONS & USAGE SECTION
Uses
for the temporary relief of ■ backache pain ■ muscle aches and pains ■ minor aches and pains of arthritis
WARNINGS SECTION
Warnings
Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.
Allergy alert:
Aspirin may cause a severe allergic reaction which may include:
■ hives
■ shock
■ facial swelling
■ asthma (wheezing)
Stomach bleeding warning:
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
■ take more or for a longer time than directed
■ take a blood thinning (anticoagulant) or steroid drug
■ are age 60 or older
■ have 3 or more alcohol drinks every day while using this product
■ have had stomach ulcers or bleeding problems
■ take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
OTC - DO NOT USE SECTION
Do not use ■ if you are allergic to aspirin or any other pain reliever/fever reducer. ■ 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
■ stomach bleeding warning applies to you
■ you have a history of stomach problems, such as heartburn
■ you have asthma
■ you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
■ you are taking a diuretic
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are taking a prescription drug for ■ gout ■ diabetes ■ arthritis
OTC - STOP USE SECTION
Stop use and ask a doctor if
■ an allergic reaction occurs. Seek medical help right away.
■ you experience any of the following signs of stomach bleeding: ■ vomit blood ■ have bloody or black stools ■ feel faint ■ have stomach pain that does not get better
■ ringing in the ears or a loss of hearing occurs
■ pain gets worse or lasts more than 10 days
■ fever gets worse or lasts more than 3 days
■ redness or swelling is present
■ new symptoms occur
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. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
DOSAGE & ADMINISTRATION SECTION
Directions
■ drink a full glass of water with each dose
Adults and children (12 years and over): take 2 caplets every 6 hours, not to exceed 8 caplets in 24 hours
Children under 12 years: do not use unless directed by 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, hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate
OTC - QUESTIONS SECTION
Questions or comments? 800-480-5855
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Unishield
Pain & Ache
Extra Strength Pain Relief
80 caplets / 2 Caplets Per Packet
Aspirin (NSAID) 500 mg, Caffeine 32.5 mg
Pain Reliever, Pain Reliever Aid
Pull To Open
This package is for Households Without young Children.
• Fast, effective relief from tough headaches
• Non-drowsy formula contains caffeine
Fast Acting Advanced Formula
Tamper Evident Unit Dose Packets