TYLENOL SINUS AND ALLERGY SEVERE - acetaminophen, diphenhydramine hydrochloride and phenylephrine hydrochloride tablet, film coated
McNeil Consumer Healthcare Div McNeil-PPC, Inc

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TYLENOL®
SINUS & ALLERGY
SEVERE

Drug Facts

Active ingredients (in each caplet)	Purpose
Acetaminophen 325 mg	Pain reliever
Diphenhydramine HCl 25 mg	Antihistamine
Phenylephrine HCl 5 mg	Nasal decongestant

Uses

temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
- headache
- sinus congestion and pressure
- nasal congestion
- runny nose and sneezing
- minor aches and pains
- itching of the nose or throat
- itchy, watery eyes
helps decongest sinus openings and passages

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

more than 12 caplets in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Do not use

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
with any other product containing diphenhydramine, even one used on skin
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.
if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

When using this product

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

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occur
pain or nasal congestion 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

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.

Directions

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

Other information

store between 20-25°C (68-77°F)
do not use if carton or blister unit is opened or broken
see side panel for lot number and expiration date

Inactive ingredients

anhydrous citric acid, carnauba wax, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, flavors, hypromellose, iron oxide, magnesium stearate, microcrystalline cellulose, potassium sorbate, propylene glycol, shellac, sodium benzoate, sodium citrate, sodium starch glycolate, sucralose, titanium dioxide, triacetin

Questions or comments?

call 1-877-895-3665

PRINCIPAL DISPLAY PANEL

NDC 50580-314-24

See New Warnings Information

TYLENOL®

SINUS
& ALLERGY

SEVERE

Alleviates Sinus Headache & Pain
Acetaminophen

Dries Runny Nose
Alleviates Itchy, Watery Eyes
Diphenhydramine

Relieves Sinus Pressure
Clears Nasal Congestion
Phenylephrine HCl

24
Cool Burst®
CAPLETS

TYLENOL SINUS AND ALLERGY SEVERE
acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	50580-314
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
acetaminophen (acetaminophen)	acetaminophen	325 mg
diphenhydramine Hydrochloride (diphenhydramine)	diphenhydramine Hydrochloride	25 mg
phenylephrine Hydrochloride (phenylephrine)	phenylephrine Hydrochloride	5 mg

Inactive Ingredients
Ingredient Name	Strength
anhydrous citric acid
carnauba wax
starch, corn
D&C yellow NO. 10
aluminum oxide
FD&C yellow NO. 6
hypromelloses
ferrosoferric oxide
magnesium stearate
cellulose, microcrystalline
potassium sorbate
propylene glycol
shellac
sodium benzoate
sodium citrate
sodium starch glycolate type a potato
sucralose
titanium dioxide
triacetin

Product Characteristics
Color	YELLOW (Light yellow)	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	TY;S;A;Severe
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	50580-314-24	2 BLISTER PACK In 1 CARTON	contains a BLISTER PACK
1		12 TABLET In 1 BLISTER PACK	This package is contained within the CARTON (50580-314-24)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/28/2010	06/29/2010

Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)

Revised: 11/2010McNeil Consumer Healthcare Div McNeil-PPC, Inc