Tylenol Cold & Flu Severe Daytime Liquid with Cool Burst, Tylenol Cold & Flu Severe NightTime Liquid with Cool Burst (McNeil Consumer)

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Product information for all dosage forms of TYLENOL Flu have been combined under this heading.

Description:    Each TYLENOL® Flu Day Non-Drowsy Gelcap contains acetaminophen 500 mg, dextromethorphan HBr 15 mg and pseudoephedrine HCl 30 mg. Each TYLENOL® Flu NightTime Gelcap contains acetaminophen 500 mg, diphenhydramine HCl 25 mg and pseudoephedrine HCl 30 mg. TYLENOL® Cold & Flu Severe NightTime Liquid with Cool Burst™: Each 30 mL (2 tablespoonsful) contains acetaminophen 1000 mg, dextromethorphan HBr 30 mg, doxylamine succinate 12.5 mg, and pseudoephedrine HCl 60 mg. TYLENOL Cold & Flu Severe Daytime Liquid with Cool Burst™:    Each 30mL (2 tablespoonful) contains acetaminophen 1000 mg, dextromethorphan HBr 30 mg, pseudoephedrine HCl 60 mg.

Actions:    TYLENOL® Flu Day Non-Drowsy Gelcaps contain a clinically proven analgesic-antipyretic, a decongestant and a cough suppressant. 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. Pseudoephedrine hydrochloride is a sympathomimetic amine which provides temporary relief of nasal congestion. Dextromethorphan is a cough suppressant which provides temporary relief of coughs due to minor throat irritations that may occur with the common cold.

TYLENOL® Flu NightTime Gelcaps contains the same clinically proven analgesic-antipyretic and decongestant as TYLENOL Flu Day Non-Drowsy Gelcaps along with an antihistamine. Diphenhydramine is an antihistamine which helps provide temporary relief of runny nose and sneezing. TYLENOL Cold & Flu Severe Daytime Liquid with Cool Burst™ contains the same clinically proven analgesic - antipyretic decongestant and cough suppressant as TYLENOL Flu Day Non-Drowsy Gelcaps . TYLENOL® Cold & Flu Severe NightTime Liquid with Cool Burst™ contains the same clinically proven analgesic-antipyretic, decongestant and cough suppressant as TYLENOL Flu Day Non-Drowsy Gelcaps along with an antihistamine. Doxylamine succinate is an antihistamine which helps provide temporary relief of runny nose and sneezing.

Uses:    TYLENOL® Flu Day Non-Drowsy Gelcaps:

temporarily relieves these cold and flu symptoms:

• minor aches and pains · headaches
• sore throat · nasal congestion
• coughs
• temporarily reduces fever

TYLENOL® Flu NightTime Gelcaps:

temporarily relieves these cold and flu symptoms:

• minor aches and pains · headaches
• sore throat · nasal congestion · runny nose · sneezing
• temporarily reduces fever

TYLENOL® Cold & Flu Severe Daytime and TYLENOL Cold & Flu Severe NightTime Liquid with Cool Burst™:

temporarily relieves these cold and flu symptoms:

• minor aches and pains · coughs
• nasal congestion · sore throat · runny nose · sneezing (NightTime only)
• temporarily reduces fever · headache

Directions:

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

TYLENOL® Flu Day Non-Drowsy Gelcaps:

TYLENOL® Flu NightTime Gelcaps:

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

TYLENOL® Cold & Flu Severe Daytime and TYLENOL Cold & Flu Severe NightTime Liquid with Cool Burst:

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

Warnings:

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.

Sore throat warning:    If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.

Do not use

• 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.
• with any other product containing acetaminophen
• with any other product containing diphenhydramine, even one used on skin (applies to TYLENOL Flu NightTime Gelcaps )

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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

TYLENOL® Flu Day Non-Drowsy Gelcaps

Ask a doctor before use if you have

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

When using this product

• do not exceed recommended dosage

Stop use and ask a doctor if

• new symptoms occur
• redness or swelling is present
• pain gets worse or lasts for more than 7 days
• fever gets worse or lasts for more than 3 days
• you get nervous, dizzy or sleepless
• cough lasts more than 7 days, comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.

TYLENOL® Flu NightTime Gelcaps

Ask a doctor before use if you have

• heart disease · glaucoma · diabetes
• thyroid disease · high blood pressure
• trouble urinating due to an enlarged prostate gland · a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

• do not exceed recommended dosage
• marked drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

Stop use and ask a doctor if

• new symptoms occur
• redness or swelling is present
• pain gets worse or lasts for more than 7 days
• fever gets worse or lasts for more than 3 days
• you get nervous, dizzy or sleepless

TYLENOL® Cold & Flu Severe Daytime and TYLENOL Cold & Flu Severe NightTime Liquid with Cool Burst™

Ask a doctor before use if you have

• heart disease · glaucoma · diabetes
• thyroid disease · cough that occurs with too much phlegm (mucus)
• high blood pressure · a breathing problem such as emphysema or chronic bronchitis · trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers (applies to TYLENOL Cold & Flu Severe NightTime only)

When using this product

• do not exceed recommended dosage
• The following apply to TYLENOL Cold & Flu Severe NightTime only
  
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Stop use and ask a doctor if

• pain, cough or nasal congestion gets worse or lasts for more than 7 days
• redness or swelling is present
• new symptoms occur
• fever gets worse or lasts for more than 3 days
• you get nervous, dizzy or sleepless (applies to TYLENOL Cold & Flu Severe NightTime only)
• cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

Other Information:

TYLENOL® Flu Day Non-Drowsy Gelcaps and TYLENOL® Flu NightTime Gelcaps:

• do not use if carton is opened or if blister unit is broken
• Store at room temperature; Avoid high humidity and excessive heat 40°C (104°F)

• Tylenol Cold & Flu Severe Daytime and NightTime Liquid with Cool Burst™
• do not use if dose cup seal, neck band or foil inner seal imprinted "Safety Seal®" is broken or missing
• Store at room temperature

Professional Information:
Overdosage Information

For overdosage information, please refer to pgs. __ - __.

Inactive Ingredients:    TYLENOL® Flu Day Non-Drowsy Gelcaps: benzyl alcohol, butylparaben, castor oil, cellulose, corn starch, edetate calcium disodium, FD&C Blue #1, FD&C Red #40, gelatin, hypromellose, iron oxide, magnesium stearate, methylparaben, propylparaben, sodium lauryl sulfate, sodium propionate, sodium starch glycolate, titanium dioxide.

TYLENOL® Flu NightTime Gelcaps: benzyl alcohol, butylparaben, castor oil, cellulose, corn starch, D&C Red #28, edetate calcium disodium, FD&C Blue #1, gelatin, hypromellose, iron oxide, magnesium stearate, methylparaben, propylparaben, sodium citrate, sodium lauryl sulfate, sodium propionate, sodium starch glycolate, titanium dioxide.

Tylenol Cold & Flu Severe Daytime liquid with Cool Burst™: citric acid, FD&C blue #1, flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium carboxymethyl cellulose, sorbitol, sucralose, sucrose

Tylenol Cold & Flu Severe NightTime liquid with Cool Burst™: citric acid, FD&C blue #1, flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium carboxymethyl cellulose, sorbitol, sucralose, sucrose

How Supplied:

TYLENOL® Flu Day Non-Drowsy Gelcaps: Burgundy- and white-colored gelcap, imprinted with "TYLENOL FLU" in gray ink--blister packs of 12 & 24. Liquid: Blue-colored--bottles of 8 fl oz with child resistant safety cap and tamper evident packaging.

TYLENOL® Flu NightTime: Gelcaps: Blue and white-colored gelcap, imprinted with "TYLENOL FLU NT" gray ink--blister packs of 12 and 24.

These products are also available in a convenience pack containing TYLENOL Flu Day (pack of 12) and TYLENOL Flu Night (pack of 12).

Tylenol Cold & Flu Severe NightTime and Daytime Liquid with Cool Burst™:

Blue colored - bottles of 8 fl. oz with child resistant safety cap and tamper evident packaging

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