PAIN STOPPER EXTRA- acetaminophen, caffeine, aspirin, salicylamide tablet
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.
----------
Active ingredients (in each tablet)
Acetaminophen 110 mg
Aspirin 162 mg
Salicylamide 152 mg
caffeine 32.4 mg
Purpose
Pain reliever, fever reducer
Uses
temporarily relieves minor aches and pains associated with:
• backache
• headaches
• colds
• toothache
• minor arthritis pain
• muscular aches
• menstrual cramps
Warnings
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
reliever/fever reducer
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 directed
Do not use:
• 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
Ask doctor before using if you have:
• upset stomach or stomach pain
• ulcers
• bleeding problems
• high blood pressure
• heart or kidney disease
• taken a diuretic
• reached age 60 or older
Ask a doctor or pharmacist before use if you are:
• taking any other drug containing an NSAID (prescription or
nonprescription)
• 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, 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.
Directions
- Adults and children 12 years of age and older:
- 2 tablets as needed for pain every 4 hours.
- Do not exceed 8 tablets in 24 hours or as directed by a doctor
- Children under 12 years, Consult a doctor
Other information
- store at room temperature
- avoid excessive heat and humidity
- tamper evident, do not use if packet is torn or open
Inactive Ingredients
FD&C Yellow #6, magnesium stearate, microcrystalline cellulose, povidone, starch, stearic acid,
MM1
Pain Stoppers Extra label