PAIN STOPPERS EXTRA - acetaminophen, caffeine, aspirin tablet, coated
North Safety Products LLC
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Do not take more than directed
the smallest effective dose should be used
adults and children 12 years of age and over; take 2 tablets with a full glass of water every 4 hours
do not take more than 16 tablets in 24 hours
do not take longer than 10 days, unless directed by a doctor
children under 12 years: ask a doctor
Reye's syndrome: Children and teenagers should not use this
medicine for chicken pox or flu symptoms before a doctor is
consulted about Reye's syndrome, a rare but serious illness
reported to be associated with aspirin.
Allergy Alert-Do not use:
• if you are allergic to aspirin or any other salicylate
• if you have ever had an allergic reaction to any other pain
Liver Warning: This product contains acetaminophen. Severe liver damage
may occur if you take:
• more than 8 tablets in 24 hours
• with other drugs containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.
• 3 or more alcoholic drinks every day while using this product
Stomach Bleeding Warning:This product contains nonsteroidal anti-inflammatory dugs (NSAIDs), which may cause 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 other drugs containing an NSAID (aspirin, ibuprofen, naproxen, or others.
• Take more or for a longer time than directedCaffeine warning: The recommended dose of this product contains about as much caffeine as a
cup of coffee.
When using this product:
limit the use of caffeine containing medications, food or beverages, too much caffeine may cause nervousness,sleeplessness,irritability,occasionally, rapid heartbeat
Do not use:
If you ever had an allergic reaction to any other pain reliever/fever reducer
• with 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
• with any other product containing acetaminophen If you are not sure
whether a drug contains acetaminophen, ask a doctor or pharmacist
Ask doctor before using if you have:
• upset stomach or stomach pain
• bleeding problems
• high blood pressure
• heart or kidney disease
• taken a diuretic
• reached age 60 or older
with any other drug containing an NSAID (prescription or nonprescription). Ask a doctor before using
with other drugs if you are not sure
• taking a blood thinning (anticoagulant) or steroid 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. These are signs of stomach bleeding
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. KEEP OUT OF REACH OF CHILDREN.
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.
KEEP OUT OF REACH OF CHILDREN. 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.
Inactive Ingredients: maltodextrin, microcrystaline cellulose, hypromellose, povidone, sodium
starch glycolate, starch, stearic acid, titanium dioxide
|PAIN STOPPERS EXTRA
acetaminophen, caffeine, aspirin tablet, coated
|Labeler - North Safety Products LLC (019777263)|
|Registrant - North Safety Products LLC (019777263)|
|ULTRAtab Laboratories, Inc.||151051757||manufacture(0498-2520)|
|Ultra Seal Corporation||085752004||repack(0498-2520)|