Acetaminophen and caffeine

Name: Acetaminophen and caffeine

What is acetaminophen and caffeine?

Acetaminophen is a pain reliever and a fever reducer.

Caffeine is used in this product to increase the pain relieving effects of acetaminophen.

Acetaminophen and caffeine is a combination medicine used to treat many conditions such as headache or muscle pain.

Acetaminophen and caffeine may also be used for purposes not listed in this medication guide.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen can damage your liver or cause death.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Acetaminophen and caffeine side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. If you have this type of reaction, you should never again take any medicine that contains acetaminophen.

Stop using acetaminophen and caffeine and call your doctor at once if you have:

  • low fever with nausea, stomach pain, and loss of appetite;

  • dark urine, clay-colored stools; or

  • jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • sleep problems (insomnia); or

  • feeling nervous, irritable, or jittery.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What do I need to tell my doctor BEFORE I take Acetaminophen and Caffeine?

  • If you have an allergy to acetaminophen and caffeine or any part of this medicine.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take acetaminophen and caffeine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some other side effects of Acetaminophen and Caffeine?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Feeling nervous and excitable.
  • Not able to sleep.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Warnings/Precautions

Concerns related to adverse effects:

• Hepatotoxicity: Acetaminophen has been associated with severe liver damage. Hepatotoxicity is usually associated with excessive intake and often involves more than one product that contains acetaminophen. Do not exceed more than 6 tablets in 24 hours and do not combine with other products that contain acetaminophen.

• Skin reactions: Serious and potentially fatal skin reactions, including acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN) have occurred rarely with acetaminophen use. Discontinue therapy at the first appearance of skin rash (FDA 2013).

Disease-related concerns:

• Ethanol use: Use with caution with concomitant alcohol use; consuming ≥3 alcoholic drinks/day may increase the risk of liver damage.

• Hepatic impairment: Use with caution in patients with hepatic impairment.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Other warnings/precautions:

• Caffeine: Contains an amount of caffeine similar to one cup of coffee; limit the use of caffeine-containing beverages or foods during therapy.

• Dosage limit: Limit acetaminophen dose from all sources (prescription, OTC, combination products) and all routes of administration (IV, oral, rectal) to <4 g/day (adults).

• Self-medication (OTC use): When used for self-medication, patients should be instructed to contact health care provider if symptoms get worse or new symptoms appear, redness or swelling is present in the painful area, fever lasts >3 days, or pain lasts longer than 10 days.

For Healthcare Professionals

Applies to acetaminophen / caffeine: oral tablet, oral tablet disintegrating

Hepatic

Acetaminophen: Rare (less than 0.1%): Severe and sometimes fatal dose dependent hepatitis in alcoholic patients, hepatotoxicity increased during fasting, hepatotoxicity from chronic acetaminophen usage[Ref]

Alcoholic patients may develop hepatotoxicity after even modest doses of acetaminophen. In healthy patients, approximately 15 grams of acetaminophen is necessary to deplete liver glutathione stores by 70% in a 70 kg person. However, hepatotoxicity has been reported following smaller doses. Glutathione concentrations may be repleted by the antidote N-acetylcysteine. One case report has suggested that hypothermia may also be beneficial in decreasing liver damage during overdose.

In a recent retrospective study of 306 patients admitted for acetaminophen overdose, 6.9% had severe liver injury but all recovered. None of the 306 patients died.

A 19 year old female developed hepatotoxicity, reactive plasmacytosis and agranulocytosis followed by a leukemoid reaction after acute acetaminophen toxicity.[Ref]

Other

Caffeine: Rare (less than 0.1%): Fibrocystic breast disease[Ref]

In one study of the effects of caffeine, 634 women with fibrocystic breast disease (compared to 1066 women without the disease), the occurrence of fibrocystic breast disease was positively associated with average daily consumption of caffeine. Women who consumed 31 to 250 mg/day of caffeine were reported to have a 1.5 times increase in odds to have the disease. Women who consumed over 500 mg/day of caffeine were reported to have a 2.3 times increase in odds.[Ref]

Gastrointestinal

One study has suggested that acetaminophen may precipitate acute biliary pain and cholestasis. The mechanism of this effect may be related to inhibition of prostaglandin and alterations in the regulation of the sphincter of Oddi.[Ref]

Acetaminophen: Rare (0.01% to 0.1%): Mostly seen in alcoholics and after overdose: Acute pancreatitis; Caffeine citrate: Very rare (less than 0.01%): Necrotizing enterocolitis in infants[Ref]

Renal

Acetaminophen: Rare (less than 0.1%): Acute tubular necrosis, interstitial nephritis; these effects are most often observed after overdose or after chronic abuse (often with multiple analgesics), or in association with acetaminophen-related hepatotoxicity[Ref]

Acute tubular necrosis usually occurs in conjunction with liver failure, but has been observed as an isolated finding in rare cases. A possible increase in the risk of renal cell carcinoma has been associated with chronic acetaminophen use as well.

A recent case control study of patients with end-stage renal disease suggested that long term consumption of acetaminophen may significantly increase the risk of end-stage renal disease particularly in patients taking more than two pills per day.[Ref]

Hypersensitivity

Acetaminophen: Rare (less than 0.1%): Anaphylaxis, fixed drug eruptions[Ref]

Hematologic

Acetaminophen: Rare (less than 0.1%): Thrombocytopenia, methemoglobinemia resulting in cyanosis in acute overdose[Ref]

Dermatologic

Acetaminophen: Rare (0.01% 0.1%): Erythematous skin rashes, bullous erythema, purpura fulminans; Very rare (less than 0.01%): Potentially fatal skin reactions: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), acute generalized exanthematous pustulosis (AGEP)[Ref]

Respiratory

Acetaminophen: Very rare (less than 0.01%): Eosinophilic pneumonia[Ref]

Cardiovascular

Acetaminophen: Very rare (less than 0.01%): Hypotension[Ref]

Nervous system

Caffeine: Frequency not reported: Caffeinism (Caffeinism is a syndrome characterized by anxiety, restlessness, and sleep disorders similar to anxiety states), aggravation of PMS

Some side effects of acetaminophen / caffeine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Usual Adult Dose for Dysmenorrhea

12 years of age or older:
Initial dose: Caffeine 130 mg-acetaminophen 1000 mg orally every 6 hours as needed
Maximum dose: Caffeine 520 mg-acetaminophen 4000 mg orally in 24 hours

Use(s): For the temporary relief of the minor pain of headache, sinusitis, colds, muscular aches, menstrual discomfort, toothache, and arthritis pain.

Usual Adult Dose for Sinusitis

12 years of age or older:
Initial dose: Caffeine 130 mg-acetaminophen 1000 mg orally every 6 hours as needed
Maximum dose: Caffeine 520 mg-acetaminophen 4000 mg orally in 24 hours

Use(s): For the temporary relief of the minor pain of headache, sinusitis, colds, muscular aches, menstrual discomfort, toothache, and arthritis pain.

Usual Adult Dose for Headache

12 years of age or older:
Initial dose: Caffeine 130 mg-acetaminophen 1000 mg orally every 6 hours as needed
Maximum dose: Caffeine 520 mg-acetaminophen 4000 mg orally in 24 hours

Use(s): For the temporary relief of the minor pain of headache, sinusitis, colds, muscular aches, menstrual discomfort, toothache, and arthritis pain.

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