TYLENOL SINUS CONGESTION AND PAIN DAYTIME- acetaminophen and phenylephrine hydrochloride tablet, film coated 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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TYLENOL® SINUS CONGESTION & PAIN

Drug Facts

Active ingredients (in each caplet)Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Phenylephrine HCl 5 mgNasal decongestant

Uses

  • temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:
    • headache
    • sinus congestion and pressure
    • nasal congestion
    • minor aches and pains
  • helps decongest sinus openings and passages
  • promotes sinus drainage
  • helps clear nasal passages
  • temporarily reduces fever

Warnings

Liver warning

This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take

  • more than 4,000 mg of acetaminophen in 24 hours
  • 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.
  • 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

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

When using this product do not exceed recommended dose

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

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 10 caplets in 24 hours
children under 12 yearsask a doctor

Other information

  • store between 20-25°C (68-77°F)
  • do not use if carton is opened or if blister unit is broken

Inactive ingredients

anhydrous citric acid, carnauba wax, corn starch, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, flavors, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, potassium sorbate, powdered cellulose, pregelatinized starch, sodium benzoate, sodium citrate, sodium starch glycolate, sucralose, titanium dioxide

Questions or comments?

call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

NDC 50580-594-24

See New Warnings Information & Directions

TYLENOL®
SINUS
CONGESTION & PAIN
For Adults

Acetaminophen, Phenylephrine HCl
Pain Reliever/Fever Reducer, Nasal Decongestant

DAYTIME
Non-Drowsy

Sinus Headache
Nasal Congestion
Sinus Pressure

24 CAPLETS

Principal Display Panel - 24 Tablet Carton
TYLENOL SINUS CONGESTION AND PAIN DAYTIME 
acetaminophen and phenylephrine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-594
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen325 mg
Phenylephrine hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine hydrochloride5 mg
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid (UNII: XF417D3PSL)  
carnauba wax (UNII: R12CBM0EIZ)  
starch, corn (UNII: O8232NY3SJ)  
D&C yellow no. 10 (UNII: 35SW5USQ3G)  
FD&C blue no. 1 (UNII: H3R47K3TBD)  
FD&C red no. 40 (UNII: WZB9127XOA)  
aluminum oxide (UNII: LMI26O6933)  
hypromelloses (UNII: 3NXW29V3WO)  
magnesium stearate (UNII: 70097M6I30)  
cellulose, microcrystalline (UNII: OP1R32D61U)  
polyethylene glycols (UNII: 3WJQ0SDW1A)  
polysorbate 80 (UNII: 6OZP39ZG8H)  
potassium sorbate (UNII: 1VPU26JZZ4)  
powdered cellulose (UNII: SMD1X3XO9M)  
sodium benzoate (UNII: OJ245FE5EU)  
sodium citrate (UNII: 1Q73Q2JULR)  
sucralose (UNII: 96K6UQ3ZD4)  
titanium dioxide (UNII: 15FIX9V2JP)  
Sodium Starch Glycolate Type A Potato (UNII: 5856J3G2A2)  
Product Characteristics
ColorGREEN (Light Green) Scoreno score
ShapeOVALSize18mm
FlavorImprint Code TYLENOL;1080
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-594-242 in 1 CARTON
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/01/201203/30/2017
Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)

Revised: 10/2015
Document Id: 6ed4b89a-cc4b-4879-b6d3-e92a3d30f5c9
Set id: 2baaea43-0b00-4dd7-a46c-7333bfc36af7
Version: 5
Effective Time: 20151030
 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division