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TYLENOL® Sinus Congestion & Pain Severe Caplets with Cool Burst™ contain a clinically proven analgesic-antipyretic, an expectorant, and a decongestant. 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. Acetaminophen is thought to produce analgesia by elevation of the pain threshold and antipyresis through action on the hypothalamic heat regulating center. Guaifenesin is an expectorant which helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive. Phenylephrine hydrochloride is a sympathomimetic amine which temporarily relieves sinus congestion and pressure.

Uses

TYLENOL® Sinus Congestion & Pain Severe Caplets with Cool Burst™:

• for the temporary relief of:
  sinus congestion and pressure, headache, nasal congestion, minor aches and pains
• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
• temporarily relieves nasal congestion due to the common cold, other upper respiratory allergies and hay fever

Dosing

TYLENOL® Sinus Congestion & Pain Severe Caplets with Cool Burst™:

• do not take more than directed (see overdose warning)

Adults and children 12 years and over

• take 2 caplets every 4 hours
• swallow whole - do not crush, chew or dissolve
• do not take more than 12 caplets in 24 hours

Children under 12 years

• do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Warnings

TYLENOL® Sinus Congestion & Pain Severe Caplets with Cool Burst™

Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers or fever reducers. Acetaminophen may cause liver damage.

Do not use:

• with any other product containing acetaminophen
• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have:

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
• chronic bronchitis, or emphysema
• cough that occurs with too much phlegm (mucus)

When using this product do not exceed recommended dosage

Stop use and ask a doctor if:

• nervousness, dizziness, or sleeplessness occurs
• pain, nasal congestion or cough gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• cough comes back or occurs with rash or headache that lasts

These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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.

Other Information:

• Each caplet contains: sodium 3 mg
• Store between 20-25ºC (68-77ºF)

PROFESSIONAL INFORMATION: OVERDOSAGE INFORMATION

Acetaminophen: 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 grams 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 grams. 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 to 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 four 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 at 24-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, (1-800-525-6115).

For additional emergency information, please contact your local poison control center.

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.

How Supplied

TYLENOL® Sinus Congestion & Pain Severe Caplets with Cool Burst™: white caplet, imprinted with "TY MS C1072" - blister packs of 24.

NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size.

Inactive Ingredients

TYLENOL® Sinus Congestion & Pain Severe Caplets with Cool Burst™: anhydrous citric acid, carnauba wax, croscarmellose sodium, flavor, hydroxypropyl cellulose, hypromellose, iron oxide, magnesium stearate, microcrystalline cellulose, potassium sorbate, pregelatinized starch, propylene glycol, shellac, sodium benzoate, sodium citrate,sucralose, titanium dioxide, triacetin