Tylenol

DRUG DESCRIPTION

American Hospital Formulary Service (Ahfs)* Classification Number

28:08.92

Generic Name

USAN: acetaminophen

INN: paracetamol CAS#: 103-90-2

Source of Supply (Trade Name and Manufacturer)

TYLENOL« (acetaminophen) - McNeil Consumer Healthcare

Physical Properties Of The Chemical Entity1

a. Structural Formula

Tylenol (acetaminophen) structural formula illustration

b. Molecular Formula

C8H9NO2

c. Molecular Weight

151.16

d. Macroscopic Appearance

Acetaminophen is a white, crystalline powder.

e. Solubility

water 1:70
boiling water 1:20
alcohol 1:10
chloroform 1:50
glycerin 1:40
ether slightly soluble

Chemical Properties

a. Structural Similarities/Differences of the Drug to Other Available Compounds or Groups of Compounds

Acetaminophen is a synthetic, nonopiate, centrally acting analgesic derived from p-aminophenol. The full chemical name is N-acetyl-p-aminophenol.

b. pKa

The pKa of acetaminophen is 9.51 at 25░C.

c. Stability of the Drug to Temperature, Light, and Moisture

Acetaminophen is stable to temperature, light, and moisture.

d. pH Range Over Which Drug is Stable in Solution

Acetaminophen is stable at a pH between 4 and 7 at 25░C.

e. pH of Commercially Available Liquid Products

Acetaminophen oral solution (ie, elixir, adult liquid) has a pH of 3.8 to 6.1 and the oral suspension (ie, infants' drops, children's suspension) has a pH of 5.4 to 6.9.

f. Osmolarity/Osmolality of Commercially Available Solutions

Extra Strength TYLENOL« acetaminophen Adult Liquid: 3058 ▒ 152 mmol/kg

Children's TYLENOL« acetaminophen Elixir: 6040 ▒ 25 mmol/kg

Because of the nature of suspension formulations, osmolarity of the TYLENOL« acetaminophen suspension products cannot be determined.

References

1. Remington's Pharmaceutical Sciences. 23rd ed. Easton, PA: Mack Publishing Company; 1995:1109-1110.

*Permission to use the Product Information Form for the American Hospital Formulary Service as modified by McNeil Consumer Healthcare has been granted by the American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, MD 20814. The answers to all questions are prepared and furnished by the manufacturer. The answers were not supplied by the Society nor are they intended to imply the endorsement of the American Society of Health-System Pharmacists; neither does the Society affirm or deny the accuracy of the answers contained herein. Copyrightę 1985, American Society of Health-System Pharmacists, Inc., all rights reserved.

What are the possible side effects of acetaminophen?

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.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • low fever with nausea, stomach pain, and loss of appetite;
  • dark urine, clay-colored stools; or
  • jaundice (yellowing of the skin or eyes).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice...

Read All Potential Side Effects and See Pictures of Tylenol

What are the precautions when taking acetaminophen (Tylenol)?

Before taking acetaminophen, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this product, tell your doctor or pharmacist your medical history, especially of: liver disease, regular use/abuse of alcohol.

Acetaminophen may cause liver damage. Daily use of alcohol, especially when combined with acetaminophen, may increase your risk for liver damage. Avoid alcohol. Check with your doctor or pharmacist for more information.

Liquid products, chewable tablets, or dissolving/effervescent tablets may contain sugar or aspartame. Caution is advised if you have diabetes,...

Read All Potential Precautions of Tylenol


Tylenol Consumer (continued)

SIDE EFFECTS: This drug usually has no side effects. If you have any unusual effects, contact your doctor or pharmacist promptly.

If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

If you do not have liver problems, the maximum dose of acetaminophen for adults is 4 grams per day (4000 milligrams). The maximum dose of acetaminophen for children is based on age/weight (check product package for details). Taking more than the maximum daily amount may cause serious (possibly fatal) liver damage. Get medical help right away if you have any of the following symptoms of liver damage: persistent nausea/vomiting, extreme tiredness, stomach/abdominal pain, yellowing eyes/skin, dark urine.

If you have liver problems, consult your doctor or pharmacist for a safe dosage of this medication.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking acetaminophen, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this product, tell your doctor or pharmacist your medical history, especially of: liver disease, regular use/abuse of alcohol.

Acetaminophen may cause liver damage. Daily use of alcohol, especially when combined with acetaminophen, may increase your risk for liver damage. Avoid alcohol. Check with your doctor or pharmacist for more information.

Liquid products, chewable tablets, or dissolving/effervescent tablets may contain sugar or aspartame. Caution is advised if you have diabetes, phenylketonuria (PKU), or any other condition that requires you to limit/avoid these substances in your diet. If you have any of these conditions, ask your doctor or pharmacist about using these products safely.

Tell your doctor if you are pregnant before using this medication.

Acetaminophen passes into breast milk. Consult your doctor before breast-feeding.


Tylenol Patient Information Including Side Effects

Brand Names: Acephen, Acetaminophen Quickmelt, Actamin, Adprin B, Anacin AF, Apra, Bromo Seltzer, Childrens Tylenol, Childrens Tylenol Meltaway, Ed-APAP, Elixsure Fever/Pain, Feverall, Genebs, Infants Tylenol Concentrated Drops, Junior Strength Tylenol, Mapap, Mapap Arthritis Pain, Mapap Infant Drops, Mapap Meltaway, Mapap Rapid Release Gelcaps, Mapap Rapid Tabs, Pain-Eze, Q-Pap, Q-Pap Extra Strength, Silapap Childrens, Silapap Infants, St. Joseph Aspirin-Free, Tactinal, Tempra, Tempra Quicklets, Tycolene, Tylenol, Tylenol 8 Hour Caplet, Tylenol 8 Hour Geltab, Tylenol Arthritis Caplet, Tylenol Arthritis Extended Release, Tylenol Arthritis Geltab, Tylenol Caplet, Tylenol Caplet Extra Strength, Tylenol Childrens, Tylenol Extra Strength, Tylenol Extra Strength Cool Caplet, Tylenol Extra Strength EZ, Tylenol Gelcap Extra Strength, Tylenol Geltab Extra Strength, Tylenol GoTabs, Tylenol Infant's Drops, Tylenol Junior Meltaway, Tylenol Rapid Release Gelcap, Tylenol Sore Throat, Tylenol Sore Throat Daytime, Uniserts, Vitapap

Generic Name: acetaminophen (oral/rectal) (Pronunciation: a SEET a MIN oh fen)

  • What is acetaminophen (Tylenol)?
  • What are the possible side effects of acetaminophen?
  • What is the most important information I should know about acetaminophen?
  • What should I discuss with my healthcare provider before taking acetaminophen?
  • How should I use acetaminophen?
  • What happens if I miss a dose?
  • What happens if I overdose?
  • What should I avoid while taking acetaminophen?
  • What other drugs will affect acetaminophen?
  • Where can I get more information?

What is acetaminophen (Tylenol)?

Acetaminophen is a pain reliever and a fever reducer.

Acetaminophen is used to treat many conditions such as headache, muscle aches, arthritis, backache, toothaches, colds, and fevers.

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

What are the possible side effects of acetaminophen?

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.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • low fever with nausea, stomach pain, and loss of appetite;
  • dark urine, clay-colored stools; or
  • jaundice (yellowing of the skin or eyes).

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 is the most important information I should know about acetaminophen?

There are many brands and forms of acetaminophen available and not all brands are listed on this leaflet.

Do not use more of this medication than is recommended. An overdose of acetaminophen can cause serious harm. The maximum amount of acetaminophen for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. Taking more acetaminophen could cause damage to your liver. If you drink more than three alcoholic beverages per day, talk to your doctor before taking acetaminophen and never use more than 2 grams (2000 mg) per day.

Do not use this medication without first talking to your doctor if you drink more than three alcoholic beverages per day or if you have had alcoholic liver disease (cirrhosis). You may not be able to use acetaminophen.

Before using acetaminophen, tell your doctor if you have liver disease or a history of alcoholism.

Do not use any other over-the-counter cough, cold, allergy, or pain medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as "APAP") is contained in many combination medicines. If you use certain products together you may accidentally use too much acetaminophen. Read the label of any other medicine you are using to see if it contains acetaminophen or APAP.

Avoid drinking alcohol while taking this medication. Alcohol may increase your risk of liver damage while taking acetaminophen.

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