FDA Label for Childrens Nortemp
View Indications, Usage & Precautions
Childrens Nortemp Product Label
The following document was submitted to the FDA by the labeler of this product Ballay Pharmaceuticals, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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.
Otc - Do Not Use
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.
Otc - Ask Doctor
Ask a doctor before use if your child has liver disease.
Otc - Ask Doctor/Pharmacist
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.
Dosage & Administration
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 directions or complete warnings for adult use.
Other information
Store between 20°-25°C (68°-77°F) in a tight container.
Each teaspoon contains: Sodium 7 mg
Inactive Ingredients
citric acid, FD&C Red No. 40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol and sucralose.
Manufactured By:
Ballay Pharmaceuticals, Inc.
200 Stillwater
Wimberley, TX 78676
Package Label.Principal Display Panel
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