TYLENOL COLD PLUS SORE THROAT EXTRA STRENGTH- acetaminophen solution
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
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.
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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 years | ask 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