TYLENOL SORE THROAT

Dosage form: liquid
Ingredients: Acetaminophen 500mg in 15mL
Labeler: McNeil Consumer Healthcare Div McNeil-PPC, Inc
NDC Code: 50580-813

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®
SORE
THROAT

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
    • muscular aches
  • 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 drug containing acetaminophen

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

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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)
  • do not take for more than 10 days unless directed by a doctor
adults and children 12 years and over
  • take 2 tablespoons (tbsp) or 30 mL in dosing cup provided every 4 to 6 hours while symptoms last
  • do not take more than 8 tablespoons 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 tablespoon contains: sodium 11 mg
  • do not use if plastic neck wrap or foil inner seal imprinted with "Safety Seal®" is broken or missing
  • store between 20-25°C (68-77°F)
  • see back label for lot number and expiration date

Inactive ingredients

citric acid, FD&C blue #1, flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium carboxymethylcellulose, sorbitol, sucralose, sucrose

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

NDC 50580-813-08

TYLENOL®
SORE
THROAT
Pain Reliever, Fever Reducer

CONTAINS 1 MEDICINE:

Sore Throat/Fever
Body Aches/Headache
Acetaminophen
500 mg per 15 mL

DAYTIME
Non-Drowsy

with INSTANT
Cool Burst™
SENSATION
8 FL OZ (240 mL)

TYLENOL  SORE THROAT
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-813
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 
FD&C blue no. 1 
polyethylene glycol 
propylene glycol 
water 
sodium benzoate 
carboxymethylcellulose sodium 
sorbitol 
sucralose 
sucrose 
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorBERRY (Berry Mint Flavored) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:50580-813-08240 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34301/01/2005
Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)

Revised: 10/2010
 
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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