CHILDRENS NORTEMP- acetaminophen solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Ballay Pharmaceuticals, Inc

INN (International Name):

ACETAMINOPHEN

Composition:

ACETAMINOPHEN 160 mg in 5 mL

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose: Pain reliever/Fever reducer ■ Temporarily reduces fever ■ Temporarily relieves minor aches and pains associated with a cold,  flu, sore throat, headache and toothache.

Authorization status:

OTC monograph not final

Summary of Product characteristics

CHILDRENS NORTEMP- ACETAMINOPHEN SOLUTION
BALLAY PHARMACEUTICALS, INC
_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 NORTEMP
_DRUG FACTS_
Active Ingredient: Acetaminophen 160mg (in each 5 mL (tsp.))
_PURPOSE_
Purpose: Pain reliever/Fever reducer
_USES_
■ Temporarily reduces fever
■ Temporarily relieves minor aches and pains associated with a cold,
flu, sore throat, headache
and 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.
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.
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.
STOP USE AND ASK A DOCTOR IF
■ new symptoms occur
■ redness or swelling is present
■ pain gets worse or lasts for more than 5 days
■ fever gets worse or lasts for more than 3 days.
These could be signs of serious condition.
KEEP OUT OF REACH OF CHILDREN. In case of accidental overdose, get
medical help or contact a Poison
Control Center immediately . Prompt medical attention is critical even
if you do not notice any signs or
symptoms.
DIRECTIONS: SHAKE WELL
Age (year)
Weight (lb)
Under 2
Under 24
2 - 3
24 - 35
4 - 5
36 - 47
6 - 8
48 - 59
9 - 10
60 - 71
11
72 - 95
Dose (tsp.)
Consult Doctor
1
1 1/2
2
2 1/2
3
All dosages may be repeated every 4 hours, but not more than 5 times
daily. THIS PRODUCT DOES NOT
CONTAIN DIR