ACETAMINOPHEN ASPIRIN AND CAFFEINE (acetaminophen, aspirin and caffeine) Dailymed
Generic: acetaminophen, aspirin and 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
IMPRINT: T 57
SHAPE: oval
COLOR: white
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Drug Facts
Active ingredients (in each tablet)
Acetaminophen USP 250 mg
Aspirin USP 250 mg (NSAID*)
Caffeine USP 65 mg
*nonsteroidal anti-inflammatory drug
Purposes
Pain relieverPain relieverPain reliever aid
Use
treats migraine
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: 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.
Allergy alert: Aspirin may cause a severe allergic reaction which may include: • hives • facial swelling • asthma (wheezing) • shock.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
• more than 2 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 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
Medication overuse headache warning: Headaches may worsen if this product is used for 10 or more days per month.
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 heart beat.
Do Not Use
• if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
• with 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 professional
• you have a headache that is different from your usual migraines
• you have the worst headache of your life
• you have fever and stiff neck
• you have headaches beginning after or caused by head injury, exertion, coughing or bending
• you experienced your first headache after the age of 50
• you have daily headaches
• you have a migraine so severe as to require bed rest
• you have liver disease • 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 • you have asthma • you have problems or serious side effects from taking pain relievers or fever reducers • you have vomiting with your migraine headache
Ask A Doctor Or Pharmacist Before Use If You Are
• taking a prescription drug for: • diabetes • gout • arthritis
• under a doctor’s care for any serious condition
• taking any other drug
• taking 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 faint • vomit blood • have bloody or black stools
• have stomach pain that does not get better
• your migraine is not relieved or worsens after first dose
• new or unexpected symptoms occur
• ringing in the ears or loss of hearing occurs
If Pregnant Or Breast-feeding,
ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in 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 overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not use more than directed
- adults: take 2 tablets with a glass of water
- if symptoms persist or worsen, ask your doctor
- do not take more than 2 tablets in 24 hours, unless directed by a doctor
- under 18 years of age: ask a doctor
Other Information
- store at controlled room temperature 20°-25°C (68°-77°F)
- close cap tightly after use
- read all product information before using. Keep this box for important information.
Inactive Ingredients
crospovidone, glyceryl monostearate, low-substituted hydroxypropyl cellulose, microcrystalline cellulose, polyvinyl alcohol, povidone, pregelatinized starch (maize), sodium lauryl sulfate, stearic acid, talc and titanium dioxide.
Questions Or Comments?
call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road, East Windsor, NJ 08520 Made in India Code: AP/DRUGS/04/2016
Package Label-principal Display Panel -250 Mg/250 Mg/65 Mgcontainer Label- 8 Tablets
AUROHEALTH NDC 58602-817-02 MIGRAINE RELIEF Acetaminophen, Aspirin (NSAID) and Caffeine Tablets USP 250 mg/250 mg/65 mg
Pain Reliever/ Pain Reliever Aid                            8 Tablets
Package Label-principal Display Panel -250 Mg/250 Mg/65 Mgcontainer Carton Label - 8 Tablets
AUROHEALTH NDC 58602-817-02 **Compare to the active ingredientsof Excedrin® Migraine Relief MIGRAINE RELIEF Acetaminophen, Aspirin (NSAID)
and Caffeine Tablets USP
250 mg/250 mg/65 mg Do not use if seal imprinted with SEALED for YOUR PROTECTION under the bottle cap is broken or missing. Pain Reliever/Pain Reliever Aid                            8 Tablets
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