TYLENOL COLD PLUS SORE THROAT EXTRA STRENGTH acetaminophen solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)

Available from:

Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

INN (International Name):

Acetaminophen

Composition:

Acetaminophen 500 mg in 15 mL

Prescription type:

OTC DRUG

Authorization status:

OTC monograph not final

Summary of Product characteristics

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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TYLENOL COLD + SORE THROAT
EXTRA STRENGTH
_DRUG FACTS_
ACTIVE INGREDIENT (IN EACH 15 ML = 1 TABLESPOON)
Acetaminophen 500 mg
PURPOS E
Pain reliever/fever reducer
US ES
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