EXTRA STRENGTH HEADACHE RELIEF Dailymed
Generic: acetaminophen aspirin caffeine is used for the treatment of Arthritis, Rheumatoid Blood Coagulation Disorders Blood Platelet Disorders Cerebral Infarction Ischemic Attack, Transient Chickenpox Child, Preschool Fever Gout Hematemesis Hemorrhagic Disorders Infant Inflammation Melena Myocardial Infarction Nasal Polyps Osteoarthritis Pain Pre-Eclampsia Pregnancy Trimester, Third Rheumatic Fever Glucosephosphate Dehydrogenase Deficiency Liver Diseases Apnea Fatigue
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Drug Facts
Otc - Active Ingredient Section
Active ingredients (in each caplet) Acetaminophen 250 mg Aspirin 250 mg (NSAID)* Caffeine 65 mg *nonsteroidal anti-inflammatory drug
Otc - Purpose Section
Purpose Pain reliever Pain reliever Pain reliever aid
Indications & Usage Section
Uses temporarily relieves minor aches and pains due to: • headache • a cold • arthritis • muscular aches • toothache • premenstrual and menstrual cramps
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 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. Allergy alert: Aspirin may cause a severe allergic reaction, which may include:
• hives • facial swelling • shock
• asthma (wheezing)
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • bulers • rash 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 8 caplets 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 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 heartbeat.
Otc - Do Not Use Section
Do not use
- 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
Otc - Ask Doctor Section
Ask a doctor before use if • 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
Otc - Ask Doctor/pharmacist Section
Ask a doctor or pharmacist before use if you are • taking a prescription drug for diabetes, gout, or arthritis • taking any other drug or are under a doctor’s care for any serious condition
Otc - Stop Use Section
Stop use and ask a doctor if
- symptoms do not improve
- new symptoms occur
- pain or fever persists or gets worse
- you experience any of the following signs of stomach bleeding:
feel faint
have bloody or black stools
vomit blood
have stomach pain that does not get better
- ringing in the ears or loss of hearing occurs, consult a doctor before taking any more of this product
Otc - Pregnancy Or Breast Feeding Section
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 Section
Keep out of reach of children In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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
Directions
• do not use more than directed • drink a full glass of water with each dose • adults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours • children under 12 years: ask a doctor
Other Safety Information
Other information
• store at 20°- 25°C (68°- 77°F) excursions permitted between 15°-30°C (59°-86°F) • use by expiration date on package
Inactive Ingredient Section
Inactive ingredients carnauba wax, colloidal silicon dioxide, hypromellose, microcrystalline cellulose, mineral oil, pregelatinized starch, povidone, sodium starch glycolate, stearic acid, titanium dioxide
Otc - Questions Section
Questions or comments?
Call 1-877-290-4008
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DISCLAIMER:
"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."
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"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."
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