Skip to Content

TYLENOL COLD PLUS SORE THROAT Extra Strength

Dosage form: solution
Ingredients: Acetaminophen 500mg in 15mL
Labeler: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
NDC Code: 50580-404

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 + SORE THROAT
Extra Strength

Drug Facts

Active ingredient (in each 15 mL = 1 tablespoon)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses
  • temporarily relieves minor aches and pains due to:
    • the common cold
    • headache
    • sore throat
  • 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

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 allergic to acetaminophen or any of the inactive ingredients in this product.

Ask a doctor before use if you have liver disease

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

Stop use and ask a doctor if
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

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 6 hours while symptoms last
  • do not take more than 90 mL (6 TBSP) (3 FL OZ) in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor
children under 12 yearsask a doctor

Other information
  • each 15 mL (1 TBSP) (½ FL OZ) contains: sodium 11 mg
  • store between 20-25°C (68-77°F)
  • do not use if neck wrap imprinted with "COLD + SORE THROAT" or foil inner seal imprinted with "SAFETY SEAL®" is broken or missing

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, FD&C blue no. 1, flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, sucrose

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

NDC 50580-404-08

See New Warning

Extra Strength
TYLENOL®

FOR ADULTS

COLD + SORE THROAT

Acetaminophen*
Pain Reliever–Fever Reducer

* 500 mg per 15 ml

8 fl oz (240 ml)

  • SORE THROAT
  • HEAD + BODY ACHES
  • FEVER

COOL
BURST

TYLENOL COLD PLUS SORE THROAT   EXTRA STRENGTH
acetaminophen solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-404
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen500 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid 
carboxymethylcellulose sodium, unspecified form 
FD&C blue NO. 1 
POLYETHYLENE GLYCOL, UNSPECIFIED 
propylene glycol 
water 
sodium benzoate 
sorbitol 
sucralose 
sucrose 
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorBERRY (berry mint) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:50580-404-08240 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34307/16/2010
Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)

 
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

Medically reviewed on Nov 30, 2017

Further information

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

Hide