Skip to Content

Tylenol Cold Plus Head Congestion Severe

Medically reviewed on November 7, 2017

Dosage form: tablet, film coated
Ingredients: Acetaminophen 325mg, Guaifenesin 200mg, Phenylephrine Hydrochloride 5mg
Labeler: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
NDC Code: 50580-566

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.

Tylenol® Cold + Head Congestion Severe

Drug Facts

Active ingredients (in each caplet)Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal decongestant

Uses
  • for the temporary relief of the following cold symptoms:
    • minor aches and pains
    • headache
    • sore throat
    • nasal congestion
    • sinus congestion and pressure
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • 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

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)

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, nasal congestion or cough 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
  • cough comes back or occurs with rash or headache that lasts

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
  • 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 10 caplets in 24 hours
children under 12 yearsask a doctor

Other information
  • each caplet contains: sodium 3 mg
  • store between 20-25°C (68-77°F)
  • do not use if carton is opened or if blister unit is broken

Inactive ingredients

carnauba wax, croscarmellose sodium, flavor, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sucralose, titanium dioxide, triacetin

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

NDC 50580-566-25

TYLENOL®
FOR ADULTS
COLD + HEAD
CONGESTION
SEVERE

Acetaminophen, Phenylephrine HCl, Guaifenesin
Pain Reliever–Fever Reducer, Nasal Decongestant, Expectorant

  • HEADACHE + BODY ACHES
  • FEVER + SORE THROAT
  • NASAL CONGESTION
  • MUCUS + CHEST CONGESTION

Actual
Size

24 CAPLETS

TYLENOL   COLD PLUS HEAD CONGESTION SEVERE
acetaminophen, guaifenesin, and phenylephrine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-566
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen325 mg
Guaifenesin (Guaifenesin) Guaifenesin200 mg
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride5 mg
Inactive Ingredients
Ingredient NameStrength
carnauba wax 
croscarmellose sodium 
hydroxypropyl cellulose (80000 MW) 
hypromellose, unspecified 
magnesium stearate 
microcrystalline cellulose 
sucralose 
titanium dioxide 
triacetin 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize20mm
FlavorImprint CodeTYLENOL;1072
Contains    
Packaging
#Item CodePackage Description
1NDC:50580-566-252 BLISTER PACK in 1 CARTON
112 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/15/2013
Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)

 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide