CHILDRENS TYLENOL- acetaminophen suspension

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

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain reliever/fever reducer temporarily: - reduces fever - relieves minor aches and pains due to: the common cold flu headache sore throat toothache - the common cold - flu - headache - sore throat - toothache

Authorization status:

OTC monograph not final

Summary of Product characteristics

CHILDRENS TYLENOL- ACETAMINOPHEN SUSPENSION
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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CHILDRENS TYLENOL
_DRUG FACTS_
ACTIVE INGREDIENT (IN EACH 5 ML)
Acetaminophen 160 mg
PURPOSE
Pain reliever/fever reducer
USES
temporarily:
reduces fever
relieves minor aches and pains due to:
the common cold
flu
headache
sore throat
toothache
WARNINGS
LIVER WARNING
This product contains acetaminophen. Severe liver damage may occur if
your child takes
more than 5 doses in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
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 your child is allergic to acetaminophen or any of the inactive
ingredients in this
product
ASK A DOCTOR BEFORE USE IF YOUR CHILD HAS liver disease
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOUR CHILD IS taking the
blood thinning
drug warfarin
WHEN USING THIS PRODUCT DO NOT EXCEED RECOMMENDED DOSE (SEE OVERDOSE
WARNING)
STOP USE AND ASK A DOCTOR IF
pain gets worse or lasts more than 5 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.
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 crit