TEMPERAL-ITO- acetaminophen suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)

Available from:

OPMX Chula Vista

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Acetaminophen 160 mg............. Pain reliever/fever reducer Pain Reliever & Fever Reducer temporarily: - reduces fever - relieves minor aches and pains due to: - sore throat - the common cold - flu - headache - toothache Stop use and ask a doctor if - new sympthoms occur - redness or swelling is present - pain gets worse or lasts more than 5 days - fever gets worse or lasts more than 3 days These could be signs of a serious condition Acetaminophen 160 mg..............Pain reliever/fever reducer Pain Reliever & Fever Reducer temporarily: - reduces fever - relieves minor aches and pains due to: - the common cold - headache - flu - sore throat - toothache Stop use and ask a doctor if - new sympthoms occur - redness or swelling is present - pain gets worse or lasts more than 5 days - fever gets worse or lasts more than 3 days These could be signs of a serious condition

Authorization status:

OTC monograph not final

Summary of Product characteristics

TEMPERAL-ITO- ACETAMINOPHEN SUSPENSION
OPMX CHULA VISTA
_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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TEMPERAL-ITO
ACTIVE INGREDIENT(IN EACH 5 ML) PURPOSE - 118 ML
Acetaminophen 160 mg............. Pain reliever/fever reducer
Pain Reliever & Fever Reducer
USES
temporarily:
reduces fever
relieves minor aches and pains due to:
sore throat
the common cold
flu
headache
toothache
WARNINGS -118 ML
LIVER WARNING: This product contains acetaminophen.
Severe liver damage may occur if your child takes takes
more than 5 doses in 24 hours. which is the maximum daily amount.
with other drugs containing acetaminophen.
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 (prescnption or
non-prescription). 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 RECOMMENED DOSE (SEE OVERDOSE
WARNING)
STOP USE AND ASK A DOCTOR IF
new sympthoms occur
redness or swelling is present
pain gets worse or lasts more than 5 days
fever gets worse or lasts more than 3 days
These could be signs of a serious condition
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
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 - 118 ML
this product does not c