The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Packaged and distributed by Lil' Drug Store Products, Inc., 9300 Earhart Ln SW, Cedar Rapids, IA
Otc - Purpose
Active ingredients (in each caplet)PurposesAcetaminophen 250 mgPain relieverAspirin 250 mg (NSAIDnonsteroidal anti-inflammatory drug)Pain relieverCaffeine 65 mgPain reliever aid
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.
- Acetaminophen may cause severe skin reactions. Symptoms may include:skin reddeningblistersrashIf a skin reaction occurs, stop use and seek medical help right away.
- Aspirin may cause a severe allergic reaction which may include:hivesfacial swellingasthma (wheezing)shock
- This product contains acetaminophen. Severe liver damage may occur if you takemore than 2 caplets in 24 hours, which is the maximum daily amountwith other drugs containing acetaminophen3 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 youare age 60 or olderhave had stomach ulcers or bleeding problemstake a blood thinning (anticoagulant) or steroid drugtake other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)have 3 or more alcoholic drinks every day while using this producttake more or for a longer time than directed
Medication Overuse Headache Warning
Headaches may worsen if this product is used for 10 or more days per month.
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
- If you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducerwith any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
Ask A Doctor Before Use If
- You have never had migraines diagnosed by a health professionalyou have a headache that is different from your usual migrainesyou have the worst headache of your lifeyou have fever and stiff neckyou have headaches beginning after or caused by head injury, exertion, coughing or bendingyou experienced your first headache after the age of 50you have daily headachesyou have a migraine so severe as to require bed restyou have liver diseasestomach bleeding warning applies to youyou have a history of stomach problems, such as heartburnyou have high blood pressure, heart disease, liver cirrhosis, or kidney diseaseyou are taking a diureticyou have asthmayou have problems or serious side effects from taking pain relievers or fever reducersyou have vomiting with your migraine headache
Ask A Doctor Or Pharmacist Before Use If You Are
- Taking a prescription drug for:diabetesgoutarthritisunder a doctor's care for any serious conditiontaking any other drugtaking any other product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer
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:feel faintvomit bloodhave bloody or black stoolshave stomach pain that does not get betteryour migraine is not relieved or worsens after first dosenew or unexpected symptoms occurringing in the ears or loss of hearing occurs
Otc - Pregnancy Or Breast Feeding
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 definitely 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
Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- Do not use more than directedadults: take 2 caplets with a glass of waterif symptoms persist or worsen, ask your doctordo not take more than 2 caplets in 24 hours, unless directed by a doctorunder 18 years of age: ask a doctor
- Store at controlled room temperature 20°-25°C (68°-77°F)read all product information before using. Keep this box for important information.
Benzoic acid, carnauba wax, FD&C blue #1, hydroxypropylcellulose, hypromellose, light mineral oil, microcrystalline cellulose, polysorbate 20, povidone, propylene glycol, simethicone emulsion, sorbitan monolaurate, stearic acid, titanium dioxide
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