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

Warnings

Liver warning

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

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

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

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

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

PRINCIPAL DISPLAY PANEL

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