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TYLENOL Cold Multi-Symptom Severe

Dosage form: liquid
Ingredients: Acetaminophen 325mg in 15mL, Dextromethorphan Hydrobromide 10mg in 15mL, Guaifenesin 200mg in 15mL, Phenylephrine hydrochloride 5mg in 15mL
Labeler: McNeil Consumer Healthcare Div McNeil-PPC, Inc
NDC Code: 50580-351

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
MULTI-SYMPTOM
SEVERE

Drug Facts

Active ingredients
(in each 15 mL = 1 tablespoon)
Purpose
Acetaminophen 325 mgPain 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
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily reduces fever

Warnings

Liver warning

This product contains acetaminophen. 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

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)
  • mL = milliliter; TBSP = tablespoon; FL OZ = fluid ounce
  • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
adults and children 12 years and over
  • take 30 mL (2 TBSP) (1 FL OZ) in the dosing cup provided every 4 hours while symptoms last
  • do not take more than 150 mL (10 TBSP) (5 FL OZ) in 24 hours, unless directed by a doctor
children under 12 yearsask a doctor

Other information
  • each 15 mL (1 TBSP) (½ FL OZ) contains: sodium 5 mg
  • store between 20-25°C (68-77°F). Do not refrigerate.
  • do not use if plastic neck wrap or foil inner seal imprinted with "SAFETY SEAL®" is broken or missing

Inactive ingredients

alcohol, anhydrous citric acid, FD&C blue no. 1, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

NDC 50580-351-08

See New Warnings Information

TYLENOL®
COLD
MULTI-SYMPTOM
SEVERE

Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr, Guaifenesin
Pain Reliever/Fever Reducer, Nasal Decongestant, Antitussive, Expectorant

Headache, Fever, Sore Throat
Nasal Congestion
Cough
Clears Out Chest Mucus

Cool Burst®

Alcohol 0.5%

8 fl oz
(240 ml)
Liquid

TYLENOL COLD   MULTI-SYMPTOM SEVERE
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-351
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (acetaminophen) Acetaminophen325 mg  in 15 mL
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide10 mg  in 15 mL
Guaifenesin (Guaifenesin) Guaifenesin200 mg  in 15 mL
Phenylephrine hydrochloride (phenylephrine) Phenylephrine hydrochloride5 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
alcohol 
anhydrous citric acid 
FD&C blue NO. 1 
glycerin 
propylene glycol 
water 
sodium benzoate 
sorbitol 
sucralose 
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorBERRY, MINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:50580-351-08240 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34108/11/2008
Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)

Revised: 09/2013
 
McNeil Consumer Healthcare Div McNeil-PPC, Inc

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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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