ACETAMINOPHEN ASPIRIN AND CAFFEINE - acetaminophen, aspirin and caffeine tablet, film coated
Aurohealth LLC
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Active ingredients (in each tablet)
Acetaminophen USP 250 mg
Aspirin USP 250 mg (NSAID*)
Caffeine USP 65 mg
*nonsteroidal anti-inflammatory drug
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 • blisters • 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.
• 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
• 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
• 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
• 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
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.
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.
crospovidone, glyceryl monostearate, low-substituted hydroxypropyl cellulose, microcrystalline cellulose, polyvinyl alcohol, povidone, pregelatinized starch (maize), sodium lauryl sulfate, stearic acid, talc and titanium dioxide.
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
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
AUROHEALTH
NDC 58602-817-02
**Compare to the active ingredients
of 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
ACETAMINOPHEN ASPIRIN AND CAFFEINE
acetaminophen, aspirin and caffeine tablet, film coated |
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Labeler - Aurohealth LLC (078728447) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
APL HEALTHCARE LIMITED | 650918514 | ANALYSIS(58602-817) , MANUFACTURE(58602-817) |