Acetaminophen, Aspirin (NSAID) and Caffeine Tablets USP
ACETAMINOPHEN ASPIRIN AND CAFFEINE by
Drug Labeling and Warnings
ACETAMINOPHEN ASPIRIN AND CAFFEINE by is a Otc medication manufactured, distributed, or labeled by Aurohealth LLC, APL HEALTHCARE LIMITED. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
ACETAMINOPHEN ASPIRIN AND CAFFEINE - acetaminophen, aspirin and caffeine tablet, film coated
Aurohealth LLC
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Acetaminophen, Aspirin (NSAID) and Caffeine Tablets USP
Drug Facts
Active ingredients (in each tablet)
Acetaminophen USP 250 mg
Aspirin USP 250 mg (NSAID*)
Caffeine USP 65 mg
*nonsteroidal anti-inflammatory drug
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 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.
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
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 mg Container Label - 8 Tablets
NDC: 58602-883-34 Primary Health
**COMPARE TO Excedrin®
Migraine active ingredients*
Acetaminophen,
Aspirin (NSAID)
and Caffeine Tablets USP
250 mg/250 mg/65 mg
Pain Reliever/Pain Reliever Aid 200 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(58602-883) , MANUFACTURE(58602-883) | |
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