Your browser does not support JavaScript! TYLENOL SINUS (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]
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RxNorm Names

TYLENOL SINUS (acetaminophen and phenylephrine hydrochloride) tablet, coated
[McNeil Consumer Healthcare Div McNeil-PPC, Inc]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Important: Read all product information before using. Keep this box for important information.

Drug Facts

Active ingredients (in each gelcap)Purpose
Acetaminophen 325 mgPain reliever
Phenylephrine HCl 5 mgNasal decongestant

Uses

  • for the temporary relief of:
    • headache
    • sinus congestion and pressure
    • nasal congestion
    • minor aches and pains
  • helps decongest sinus openings and passages
  • promotes sinus drainage
  • helps clear nasal passages

Warnings

Liver warning

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

  • more than 12 gelcaps 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.
  • 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 dosage

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

adults and children 12 years and over
  • take 2 gelcaps every 4 hours
  • do not take more than 12 gelcaps 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

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

Inactive ingredients

benzyl alcohol, black iron oxide, butylparaben, carboxymethylcellulose sodium, colloidal silicon dioxide, corn starch, D&C yellow #10, edetate calcium disodium, FD&C blue #1, FD&C blue #2, FD&C red #40, gelatin, hypromellose, methylparaben, microcrystalline cellulose, polyethylene glycol, polysorbate 80, powdered cellulose, pregelatinized starch, propylene glycol, propylparaben, red iron oxide, sodium lauryl sulfate, sodium propionate, sodium starch glycolate, stearic acid, titanium dioxide, yellow iron oxide

Questions or comments?

call 1-877-895-3665

PRINCIPAL DISPLAY PANEL

NDC 50580-229-24

See New Warnings Information

TYLENOL®

SINUS
CONGESTION & PAIN

Alleviates Sinus Headache & Pain
Acetaminophen

Relieves Sinus Pressure
Clears Nasal Congestion
Phenylephrine HCl

24 RR GELCAPS

Rapid Release
GELS

DAYTIME
Non-Drowsy

Principal Display Panel
TYLENOL SINUS   CONGESTION AND PAIN
acetaminophen and phenylephrine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50580-229
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen325 mg
Phenylephrine hydrochloride (Phenylephrine) Phenylephrine hydrochloride5 mg
Inactive Ingredients
Ingredient NameStrength
benzyl alcohol 
ferrosoferric oxide 
butylparaben 
carboxymethylcellulose sodium 
silicon dioxide 
starch, corn 
D&C yellow NO. 10 
edetate calcium disodium 
FD&C Blue NO. 1 
FD&C Blue NO. 2 
FD&C red NO. 40 
gelatin 
hypromelloses 
methylparaben 
cellulose, microcrystalline 
polyethylene glycol 
polysorbate 80 
powdered cellulose 
propylene glycol 
propylparaben 
ferric oxide red 
sodium lauryl sulfate 
sodium propionate 
sodium starch glycolate type a potato 
stearic acid 
titanium dioxide 
ferric oxide yellow 
Product Characteristics
ColorRED, GREEN (Red and green with gray subcoat band) Scoreno score
ShapeOVALSize19mm
FlavorImprint Code TY;S;CP
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-229-022500 in 1 TRAY
12 in 1 POUCH
2NDC:50580-229-242 in 1 CARTON
212 in 1 BLISTER PACK
3NDC:50580-229-484 in 1 CARTON
312 in 1 BLISTER PACK
4NDC:50580-229-721 in 1 CARTON
472 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/01/2007
Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)

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

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