ACETAMINOPHEN suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Healthlife of USA

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Fever reducer/ pain reliever Temporarily: - reduces fever - relieves minor aches and pains due to: - the common cold - flu - headache - sore throat - toothache - with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whetgher 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 liver disease taking the blood thinning drug warfarin - new symptoms 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

ACETAMINOPHEN- ACETAMINOPHEN SUSPENSION
HEALTHLIFE OF USA
_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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CHILDREN'S ACETAMINPHEN ORAL SUSPENSION
PAIN RELIEVER/ FEVER REDUCER
DRUG FACTS
ACTIVE INGREDIENT (IN EACH 5ML)
Acetaminophen 160mg
PURPOS E
Fever reducer/ pain reliever
US ES
Temporarily:
1. reduces fever
2. 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
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.
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.
DO NOT USE
with any other drug containing acetaminophen (prescription or
nonprescription). If you are not sure
whetgher 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
new symptoms 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:
In case of overdose, get medical help or contact a Poison Control
Center right away. Quick medical
attention is critical for adults a