TYLENOL® SINUS & ALLERGY SEVERE

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 mgPain reliever
Diphenhydramine HCl 25 mgAntihistamine
Phenylephrine HCl 5 mgNasal 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 yearsdo 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 TypeHUMAN OTC DRUGNDC Product Code (Source)50580-314
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
acetaminophen (acetaminophen) acetaminophen325 mg
diphenhydramine Hydrochloride (diphenhydramine) diphenhydramine Hydrochloride25 mg
phenylephrine Hydrochloride (phenylephrine) phenylephrine Hydrochloride5 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorYELLOW (Light yellow) Score no score
ShapeOVALSize17mm
FlavorImprint Code TY;S;A;Severe
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
150580-314-242 BLISTER PACK In 1 CARTONcontains a BLISTER PACK
112 TABLET In 1 BLISTER PACKThis package is contained within the CARTON (50580-314-24)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/28/201006/29/2010

Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)
Revised: 11/2010McNeil Consumer Healthcare Div McNeil-PPC, Inc