Acetaminophen (0005)
[ a-set-a-mee'-noe-fen ]
| Ingredients: |
Acetaminophen |
| Indications: |
Arthritis, osteoarthritis; Cramps, menstrual; Fever; Headache, tension; Pain, mild |
| Pregnancy Category: |
(none)
|
| FDA Approved: |
pre- 1938 |
| Classes: |
Analgesics, non- narcotic; Antipyretics; Orphan Drugs |
| Brand Names: |
Abenol
-
Canada
;
Acamol
-
Chile, Israel
;
Acamoli Forte suppositories for Kids
-
Israel
;
Acet
-
Malaysia, Philippines
;
Acetalgin
-
Switzerland
;
Acetam
-
Peru
;
Acetamol
-
Italy
;
ACET suppositories
-
Singapore
;
Adorem
-
Colombia
;
Afebrin
-
Hong-kong, Indonesia, Philippines
;
Algiafin
-
Chile
;
Alphagesic
-
Indonesia
;
Alvedon
-
Sweden
;
Amol
-
MIDDLEEAST(Except
Israel
)
;
A-Mol
-
Thailand
;
Anaflon
-
Germany
;
Analgiser
-
MIDDLEEAST(Except
Israel
)
;
Apirex
-
France
;
Arfen
-
AFRICA(Except
South-africa
); Malaysia
;
Atamel
-
Peru
;
Benuron
-
Japan
;
Ben-U-Ron
-
Belgium, Germany, Portugal, Switzerland
;
Biogesic
-
Indonesia, Philippines, Thailand
;
Biogesic Suspension
-
Hong-kong
;
Bodrex
-
Indonesia
;
Brenal
-
Philippines
;
Calapol
-
Indonesia
;
Calodol
-
Philippines
;
Calpol
-
AFRICA(Except
South-africa
), CARIBBEAN(Except
Puerto-rico
), MIDDLEEAST(Except
Israel
); India, Ireland, Japan, Thailand
;
Causalon
-
Argentina
;
Cemol
-
Thailand
;
Christamol
-
Hong-kong
;
Claradol
-
Morocco
;
Clocephen
-
Philippines
;
Crocin
-
India
;
Daga
-
Thailand
;
Datril
-
Mexico, Venezuela
;
Depyretin
-
Taiwan
;
Dirox
-
Argentina
;
Dismifen
-
Mexico
;
Dolex
-
Uruguay
;
Dolex 500
-
Colombia, Uruguay
;
Doliprane
-
France, Morocco
;
Dolitabs
-
France
;
Dolofen
-
Colombia
;
Dolomol
-
MIDDLEEAST(Except
Israel
)
;
Dolorol
-
South-africa
;
Dolotemp
-
Mexico
;
Doltem
-
Peru
;
Drilan
-
Philippines
;
Dymadon
-
Australia
;
Efferalgan 500
-
Costa-rica, Dominican-republic, El-salvador, Guatemala, Honduras, Israel, Nicaragua, Panama
;
Efferalganodis
-
France
;
Eraldor
-
Ecuador
;
Expandol
-
France
;
Fervex
-
Brazil
;
Flurinol
-
Philippines
;
Fortolin
-
China
;
Gelocatil
-
Spain
;
Geluprane 500
-
France
;
Gunaceta
-
Indonesia
;
Kamolas
-
Indonesia
;
Kyofen
-
Colombia
;
Lemgrip
-
Belgium
;
Lotemp
-
Thailand
;
Malidens
-
India
;
Mebinol
-
Peru
;
Meforagesic
-
Philippines
;
Metagesic
-
Philippines
;
Mexalen
-
Austria, Czech-republic, Hungary
;
Milidon 500
-
Singapore
;
Minopan
-
Korea
;
Mypara
-
Thailand
;
Nalgesik
-
Indonesia
;
Napa
-
Singapore
;
Napamol
-
South-africa
;
Naprex
-
Indonesia
;
NEBS
-
Japan
;
Nektol 500
-
Philippines
;
Nilapur
-
Indonesia
;
Pacemol
-
Brazil, Singapore
;
Pacimol
-
India
;
Pamol
-
Denmark, New-zealand
;
Panadol
-
AFRICA(Except
South-africa
), AUSTRALIA, MIDDLEEAST; Belgium, Brazil, Bulgaria, Chile, England, Finland, France, Greece, Hong-kong, Indonesia, Ireland, Italy, Korea, Netherlands, Switzerland, Taiwan, Thailand, Uruguay
;
Panadol Actifast
-
Malaysia, Singapore
;
Panamax
-
Australia
;
Panodil
-
Denmark, Norway, Sweden
;
Paracet
-
Norway
;
Parageniol
-
Paraguay
;
Paragin
-
Thailand
;
Paralgin
-
Australia
;
Paralief
-
Ireland
;
Paramidol
-
Peru
;
Paramol
-
Israel, Taiwan
;
Parapaed
-
Germany
;
Parapaed Junior
-
New-zealand
;
Parapaed Six Plus
-
New-zealand
;
Paratabs
-
New-zealand
;
Parvid
-
Philippines
;
Paximol
-
Singapore
;
Pedipan
-
Korea
;
Penral-Night
-
Korea
;
Pinex
-
Norway
;
Poro
-
Malaysia
;
Predimol
-
India
;
Puernol
-
Italy
;
Raperon
-
Korea
;
Rapidol
-
Chile
;
Reliv
-
Sweden
;
Remedol
-
CARIBBEAN(Except
Puerto-rico
)
;
Revanin
-
AFRICA(Except
South-africa
)
;
Rhinapen elixir
-
Korea
;
Roxamol Gelcaps
-
Israel
;
Salzone
-
AFRICA(Except
South-africa
)
;
Saridon
-
Colombia
;
Serimol
-
Hong-kong
;
Setamol
-
Australia
;
Sinedol
-
Dominican-republic
;
Taganopain
-
Korea
;
Tamifen
-
Ecuador
;
Tempra
-
Belgium, Canada, Costa-rica, Ecuador, El-salvador, Greece, Guatemala, Honduras, Indonesia, Japan, Mexico, Nicaragua, Panama, Spain, Thailand
;
Tempte
-
Taiwan
;
Temzzard
-
Mexico
;
Termofren
-
Costa-rica, Dominican-republic, El-salvador, Guatemala, Honduras, Nicaragua, Panama
;
Turpan
-
Indonesia
;
Tylenol
-
US; Australia, Austria, Brazil, Bulgaria, Canada, China, France, Germany, Hong-kong, Israel, Japan, Korea, Mexico, Philippines, Portugal, Spain, Switzerland, Thailand, Venezuela
;
Tylenol Extra Fuerte
-
Paraguay, Peru
;
Tylenol Forte
-
MIDDLEEAST
;
Tylex
-
Costa-rica, Dominican-republic, El-salvador, Guatemala, Honduras, Nicaragua, Panama
;
Winadol
-
Colombia, Venezuela
;
Winasorb
-
Costa-rica, Dominican-republic, El-salvador, Guatemala, Honduras, Nicaragua, Panama
;
Xebramol
-
Thailand
;
Zetifen
-
Philippines
;
Zolben
-
Venezuela
;
Zydinol
-
Philippines
;
|
| DEA schedules: |
(none)
|
| Cost of therapy: |
$0.54
(
Pain/Fever ;
Generic (Advance) ;
325 mg ;
8 tablets/day ;
7 day supply
)
$4.17
(
Pain/Fever ;
Tylenol ;
325 mg ;
8 tablets/day ;
7 day supply
)
|
DESCRIPTION
|
| |
Note: The trade names have been used throughout this monograph for clarity.
Each Extra Strength Tylenol Gelcap, Geltab, Caplet, or Tablet contains acetaminophen 500 mg.
Each 15 ml (½ fl oz or 1 tablespoonful) of Extra Strength Tylenol Adult Liquid Pain Reliever contains 500 mg acetaminophen (alcohol 7%).
Each Regular Strength Tylenol Caplet or Tablet contains acetaminophen 325 mg.
Each Tylenol Arthritis Pain Extended Relief Caplet contains acetaminophen 650 mg.
Inactive Ingredients
|
| |
Extra Strength Tylenol:
- Tablets: Celluose, corn starch, magnesium stearate, sodium starch glycolate.
- Caplets: Cellulose, corn starch, FD&C red no. 40, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol, sodium starch
glycolate.
- Gelcaps: Benzyl alcohol, blue no. 1 and no. 2, butylparaben, castor oil, cellulose, corn starch, edetate calcium disodium, gelatin,
hydroxypropyl methylcellulose, magnesium stearate, methylparaben, propylparaben, red no. 40, sodium lauryl sulfate, sodium
propionate, sodium starch glycolate, titanium dioxide, and yellow no. 10.
- Geltabs: Benzyl alcohol, blue no. 1 and 2, butylparaben, castor oil, cellulose, corn starch, edetate calcium disodium, gelatin, hydroxypropyl
methylcellulose, magnesium stearate, methylparaben, propylparaben, red no. 40, sodium lauryl sulfate, sodium propionate, sodium
starch glycolate, titanium dioxide, and yellow no. 10.
Extra Strength Tylenol Adult Liquid Pain Reliever:
- Alcohol (7%), citric acid, D&C yellow no. 10, FD&C blue no. 1, FD&C yellow no. 6, flavor, glycerin, polyethylene glycol, purified
water, sodium benzoate, sorbitol, sucrose.
Regular Strength Tylenol:
- Tablets: Cellulose, corn starch, magnesium stearate, sodium starch glycolate.
Tylenol Arthritis Pain Extended Relief Caplets:
- Corn starch, hydroxyethyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, povidone,
powdered cellulose, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin.
|
|
CLINICAL PHARMACOLOGY
|
| |
Acetaminophen is a clinically proven analgesic and antipyretic. Acetaminophen produces analgesia by elevation of the pain
threshold and antipyresis through action on the hypothalamic heat regulating center. Acetaminophen is equal to aspirin in
analgesic and antipyretic effectiveness and it is unlikely to produce many of the side effects associated with aspirin and
aspirin- containing products.
Tylenol Arthritis Extended Relief uses a unique, patented bilayer caplet. The first layer dissolves quickly to provide prompt relief while the second layer
is time released to provide up to 8 hours of relief.
|
INDICATIONS AND USAGE
|
| |
For the temporary relief of minor aches and pains associated with headache, muscular aches, backache, minor arthritis pain,
common cold, toothache, menstrual cramps and for the reduction of fever.
|
WARNINGS
|
| |
Extra Strength Tylenol Gelcaps, Geltabs, Caplets, or Tablets, Extra Strength Tylenol Adult Liquid Pain Reliever, Regular Strength
Tylenol Tablets
|
| |
Alcohol Warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/
fever reducers. Acetaminophen may cause liver damage.
Do not use if carton is opened or red neck wrap or foil seal imprinted with "Safety Seal" is broken.
Do not use:
| • |
With any other product containing acetaminophen.
|
| • |
For more than 10 days for pain unless directed by a doctor.
|
| • |
For more than 3 days for fever unless directed by a doctor.
|
Stop using and ask a doctor if:
| • |
Symptoms do not improve.
|
| • |
New symptoms occur.
|
| • |
Pain or fever persists or gets worse.
|
| • |
Redness or swelling is present.
|
Do not exceed recommended dose. Keep this and all drugs out of the reach of children. In case of accidental overdose, contact a physician or poison control
center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any
signs or symptoms. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before
using this product.
|
Tylenol Arthritis Pain Extended Relief Caplets
|
| |
Alcohol Warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/
fever reducers. Acetaminophen may cause liver damage.
Do not use if carton is opened or red neck wrap or foil inner seal imprinted with "Safety Seal" is broken. Do not take for pain for more than 10 days or for fever for more than 3 days unless directed by a physician. If pain or fever
persists, or gets worse, if new symptoms occur, or if redness or swelling is present, consult a physician because these could
be signs of a serious condition. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional
before using this product. Keep this and all drugs out of the reach of children. In case of accidental overdose, contact a
physician or poison control center immediately. Prompt medical attention is critical for adults as well as for children even
if you do not notice any signs or symptoms. Do not use with other products containing acetaminophen.
|
|
PRECAUTIONS
|
| |
If a rare sensitivity reaction occurs, the drug should be discontinued.
|
OVERDOSAGE
|
| |
Acetaminophen in massive overdosage may cause hepatic toxicity in some patients. In adults and adolescents (≥12 years of age),
hepatic toxicity may occur following ingestion of greater than 7.5 to 10 g over a period of 8 hours or less. Fatalities are
infrequent (less than 3- 4% of untreated cases)and have rarely been reported with overdoses of less than 15 g. In children
(<12 years of age), an acute overdosage of less than 150 mg/ kg has not been associated with hepatic toxicity. Early symptoms
following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and
laboratory evidence of hepatic toxicity may not be apparent until 48- 72 hours postingestion. In adults and adolescents, any
individual presenting with an unknown amount of acetaminophen ingested or with a questionable or unreliable history about
the time of ingestion should have a plasma acetaminophen level drawn and be treated with N - acetylcysteine. For full prescribing information, refer to the N - acetylcysteine package insert. Do not await results of assays for plasma acetaminophen levels before initiating treatment
with N - acetylcysteine. The following additional procedures are recommended: Promptly initiate gastric decontamination of the stomach. A plasma acetaminophen assay should be obtained as early as possible,
but no sooner than 4 hours following ingestion. If an acetaminophen extended release product is involved, it may be appropriate to obtain an additional plasma acetaminophen level 4- 6 hours following the initial
acetaminophen level. If either acetaminophen level plots above the treatment line on the acetaminophen overdose nomogram, N - acetylcysteine treatment should be continued for a full course of therapy. Liver function studies should be obtained initially
and repeated at24 hour intervals.
Serious toxicity or fatalities have been extremely infrequent following an acute acetaminophen overdose in young children,
possibly because of differences in the way they metabolize acetaminophen. In children, the maximum potential amount ingested
can be more easily estimated. If more than 150 mg/ kg or an unknown amount was ingested, obtain a plasma acetaminophen level
as soon as possible, but no sooner than 4 hours following ingestion. If an acetaminophen extended release product is involved, it may be appropriate to obtain an additional plasma acetaminophen level 4- 6 hours following the initial
acetaminophen level. If either acetaminophen level plots above the treatment line on the acetaminophen overdose nomogram, N - acetylcysteine treatment should be initiated and continued for a full course of therapy. If an assay cannot be obtained
and the estimated acetaminophen ingestion exceeds 150 mg/ kg, dosing with N - acetylcysteine should be initiated and continued for a full course of therapy.
For additional emergency information, call your regional poison center or call the Rocky Mountain Poison Center toll- free
at 1- 800- 525- 6115.
Alcohol Information: Chronic heavy alcohol abusers may be at increased risk of liver toxicity from excessive acetaminophen use, although reports
of this event are rare. Reports usually involve cases of severe chronic alcoholics and the dosages of acetaminophen most often
exceed recommended doses and often involve substantial overdose. Healthcare professionals should alert their patients who
regularly consume large amounts of alcohol not to exceed recommended doses of acetaminophen.
|
DOSAGE AND ADMINISTRATION
|
| |
Extra Strength Tylenol Gelcaps, Geltabs, Caplets, or Tablets:
- Adults and children 12 years of age and older: Take 2 gelcaps, geltabs, caplets, or tablets every 4- 6 hours as needed. Do not take more than 8 gelcaps, geltabs, caplets
or tablets in 24 hours, or as directed by a doctor.
- Children under 12 years: Do not use this adult Extra Strength product in children under 12 years of age. This will provide more than the recommended
dose (overdose) of Tylenol and could cause serious health problems.
Extra Strength Tylenol Adult Liquid Pain Reliever:
- Adults and children 12 years of age and older: Take 2 tablespoons (tbsp) in dose cup provided every 4- 6 hours as needed. Do not take more than 8 tablespoons in 24 hours,
or as directed by a doctor.
- Children under 12 years: Do not use this adult Extra Strength product in children under 12 years of age. This will provide more than the recommended
dose (overdose) of Tylenol and could cause serious health problems.
Regular Strength Tylenol Tablets:
- Adults and Children 12 years of Age and Older: Take 2 tablets every 4- 6 hours as needed. Do not take more than 12 tablets in 24 hours, or as directed by a doctor.
- Children 6- 11 years of age: Take 1 tablet every 4- 6 hours as needed. Do not take more than 5 tablets in 24 hours.
- Children under 6 years of age: Do not use this adult Regular Strength product in children under 6 years of age. This will provide more than the recommended
dose (overdose) of Tylenol and could cause serious health problems.
Tylenol Arthritis Pain Extended Relief Caplets:
- Adults and children 12 years of age and older: Take 2 caplets every 8 hours, not to exceed 6 caplets in any 24 hour period. TAKE 2 CAPLETS WITH WATER, SWALLOW EACH CAPLET
WHOLE. DO NOT CRUSH, CHEW, OR DISSOLVE THE CAPLET. Not for use in children under 12 years of age.
|
HOW SUPPLIED
|
| |
Extra Strength Tylenol:
- Tablets: Colored white, imprinted "TYLENOL" and "500";. Store at room temperature.
- Caplets: Colored white, imprinted "TYLENOL 500 mg". Store at room temperature.
- Gelcaps: Colored yellow and red, imprinted "Tylenol 500". Store at room temperature; avoid high humidity and excessive heat 40°C (104°F).
- Geltabs: Colored yellow and red, imprinted "Tylenol 500". Store at room temperature; avoid high humidity and excessive heat 40°C (104°F).
Extra Strength Tylenol Adult Liquid Pain Reliever:
- Mint- flavored liquid (colored green) 8 fl oz tamper- evident bottle with child resistant safety cap and special dosage cup.
Store at room temperature.
Regular Strength Tylenol:
- Tablets: Colored white, scored, imprinted "TYLENOL" and "325". Store at room temperature.
Tylenol Arthritis Pain Extended Relief:
- Caplets: Colored white, engraved "TYLENOL ER". Store at room temperature. Avoid excessive heat (40°C).
|
PRODUCT IDENTIFICATION
|
| |
None Available |
|