OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENT IN EACH TABLET- ACETAMINOPHEN 110 MG, ASPIRIN 162 MG, CAFFEINE 32.4 MG, SALICYLAMIDE 152 MG
OTC - PURPOSE SECTION
PAIN RELIEVER/FEVER REDUCER
INDICATIONS & USAGE SECTION
Uses:
temporarily relieves minor aches and pains associated with:
• headaches • colds • toothache • minor arthritis pain • muscular aches • menstrual cramps • backache
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 behaviour 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.
Alergy 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.
Allergy Alert: Aspirin may cause a severe allergic reaction, which may include: • hives • facial swelling • asthma (wheezing) • shock
Liver Warning:
This product contains Acetaminophen. Severe liver damage may occur if you take:
• more than 8 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
Stomach Bleeding Warning:
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
• are age 60 or older
• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take with other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
• have 3 or more alcoholic drinks every day while using this product
• take more or for a longer time than directed
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 heart beat.
Do not use:
• with any other product containing acetaminophen (prescription or nonprescription). This will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns.
• with any other pain reliever/fever reducer
• if you are allergic to aspirin
• if you have ever had an allergic reaction to any other pain reliever/fever reducer
• for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor
Ask doctor before using if you have:
• stomach problems (such as heartburn, upset stomach or stomach pain)
• stomach bleeding warning applies to you
• gastric ulcers • bleeding problems
• you have asthma, high blood pressure, heart disease, liver disease, or kidney disease
• you are taking a diuretic
Ask a doctor or pharmacist before use if you are taking a prescription drug for:
•anticoagulation (thinning of blood) • diabetes • gout • arthritis
• und a doctor's care for any serious condition
• taking any other drug
When using this product do not exceed recommended dose.
Stop use and ask a doctor if:
• ringing in the ears or loss of hearing occurs
• pain or fever persists or gets worse
• new symptoms occur
• redness or swelling is present
• you feel faint, vomit blood or have bloody or black stools, have stomach pain that does not get better. These are signs of stomach bleeding.
• an allergic reaction occurs.
Seek medical help right away.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding baby, ask a health professional before use. IT IS ESPECIALLY IMPORTANT NOT TO USE ASPIRIN
DURING THE LAST 3 MONTHS OF 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
In case of overdose, get medical help or contact a Poison Control Center 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
Adults and children 12 years of age and older:Take 2 tablets every 4 hours as
needed, with a full glass of water. Do not exceed 8 tablets in any 24 hour period.
Children under 12 years: ask a doctor.
INACTIVE INGREDIENT SECTION
FD&C yellow #6, magnesium stearate, microcrystalline cellulose, povidone, starch and stearic acid