Pain Stoppers EX
Dosage form: tablet, coated
Ingredients: ACETAMINOPHEN 250mg, CAFFEINE 65mg, ASPIRIN 250mg
Labeler: North Safety Products LLC
NDC Code: 0498-2521
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.
Acetaminophen 250 mg
Aspirin 250 mg
Caffeine 65 mg
Pain reliever/Fever reducer
for the temporary relief of minor aches and pain with a headache
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 sigh of Reye's syndrome, a rare but serious illness.
Allergy alert: Aspirin may cause a severe allergic reaction which may include:
- facial swelling
- asthma (wheezing)
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
If a skin reaction occurs, stop use and seek medical help right away.
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 16 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 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
Caffeine 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
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- for more than 10 days for pain unless directed by a doctor
- for more than 3 days for fever unless directed by a doctor
- stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- you are taking a diuretic
- new symptoms occur
- pain or fever persists or gets worse
- you experience any of the following signs of stomach bleeding:
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
- if ringing in the ears or a loss of hearing occurs, consult a doctor before taking any more of this product.
If pregnant or breast feeding,ask a health care professional before use.
It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely 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 accidental 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.
- 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
- store at a controlled room temperature 15 o-30 o C (59 o-86 o F)
- do not use if package is opened or torn
maltodextrin, microcrystaline cellulose, hypromellose, povidone, sodium
starch glycolate, starch, stearic acid, titanium dioxide
|PAIN STOPPERS EX
acetaminophen, caffeine, aspirin tablet, coated
|PAIN STOPPERS EXTRA
acetaminophen, caffeine, aspirin tablet, coated
|Labeler - North Safety Products LLC (019777263)|
|Registrant - North Safety Products LLC (019777263)|
|North Safety Products LLC||019777263||repack(0498-2520, 0498-2521)|
|Ultra Seal Corporation||085752004||repack(0498-2520), pack(0498-2521)|
|ULTRAtab Laboratories, Inc.||151051757||manufacture(0498-2520, 0498-2521)|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.