NORTEMP- acetaminophen solution/ drops

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 80 mg in 0.8 mL

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose: Fever reducer/pain reliever temporarily: ■ reduces fever ■ relieves minor aches and pains due to: ■ the common cold ■ flu ■ headaches ■ sore throat  ■ toothaches - 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. ■ 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.

Authorization status:

OTC monograph not final

Summary of Product characteristics

NORTEMP - ACETAMINOPHEN SOLUTION/ DROPS
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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NORTEMP INFANTS DROPS
DRUG FACTS
Active Ingredient: Acetaminophen 80 mg (in each 0.8 mL)
Purpose: Fever reducer/pain reliever
US ES
temporarily:
■ reduces fever
■ relieves minor aches and pains due to: ■ the common cold ■ flu
■ headaches ■ sore throat ■
toothaches
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.
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 DOSAGE. (SEE OVERDOSE WARNING)
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.
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 (1-800-222-1222) .
Quick medical attention is critical even if you do not notice any
signs or symptoms.
DIRECTIONS
■ this product d