Tylenol Cold Head Congestion Severe

Dosage form: tablet, film coated
Ingredients: Acetaminophen 325mg, Dextromethorphan Hydrobromide 10mg, Guaifenesin 200mg, Phenylephrine Hydrochloride 5mg
Labeler: McNeil Consumer Healthcare Div. McNeil-PPC, Inc
NDC Code: 50580-261

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 mg ..........................................Pain reliever/fever reducer
Dextromethorphan HBr 10 mg ................................Cough suppressant
Guaifenesin 200 mg ................................................Expectorant
Phenylephrine HCl 5 mg .........................................Nasal decongestant

Uses
  • for the temporary relief of the following cold/flu symptoms:
    • minor aches and pains
    • headache
    • sore throat
    • nasal congestion
    • cough
    • impulse to cough
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily reduces fever

Warnings

Alcohol warning

If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers or fever reducers. Acetaminophen may cause liver damage.

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 product containing acetaminophen
  • 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.

Ask a doctor before use if you have

  • 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)

When using this product do not exceed recommended dosage

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

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
  • 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 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
  • 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
  • see side panel for lot number and expiration date

Inactive ingredients

carnauba wax, croscarmellose sodium, D&C yellow #10 aluminum lake, flavor, hydroxypropyl cellulose, hypromellose, iron oxide, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, shellac, sucralose, titanium dioxide

Questions or comments?

call 1-877-895-3665 (English) or 1-888-466-8746 (Spanish)

PRINCIPAL DISPLAY PANEL

NDC 50580-261-24

TYLENOL®

COLD
HEAD CONGESTION

SEVERE

Pain Reliever/Fever Reducer, Nasal Decongestant, Cough Suppressant, Expectorant

CONTAINS 4 MEDICINES:

Headache/Sore Throat - Acetaminophen
Nasal Congestion - Phenylephrine HCl
Coughing - Dextromethorphan HBr
Chest Congestion - Guaifenesin

DAYTIME
Non-Drowsy

24
Cool Burst™
CAPLETS

TYLENOL COLD  HEAD CONGESTION SEVERE
acetaminophen, dextromethorphan hbr, guaifenesin and phenylephrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-261
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen325 mg
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan10 mg
Guaifenesin (Guaifenesin) Guaifenesin200 mg
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine5 mg
Product Characteristics
ColorYELLOWScoreno score
ShapeOVALSize19mm
FlavorImprint Code TY;Cold;Severe
Contains    
Packaging
#Item CodePackage Description
1NDC:50580-261-022 TABLET, FILM COATED (TABLET) in 1 POUCH
2NDC:50580-261-5050 POUCH (POUCH) in 1 CARTON
22 TABLET, FILM COATED (TABLET) in 1 POUCH
3NDC:50580-261-242 BLISTER PACK (BLISTER PACK) in 1 CARTON
312 TABLET, FILM COATED (TABLET) in 1 BLISTER PACK
4NDC:50580-261-492 CARTON (CARTON) in 1 PACKAGE, COMBINATION
42 BLISTER PACK (BLISTER PACK) in 1 CARTON
412 TABLET, FILM COATED (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/01/2006
Labeler - McNeil Consumer Healthcare Div. McNeil-PPC, Inc (878046358)

Revised: 10/2009
 
McNeil Consumer Healthcare Div. McNeil-PPC, Inc

See also...

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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