Childrens Nortemp
FDA Label NDC 63162-510

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ballay Pharmaceuticals, Inc for the product Childrens Nortemp (NDC 63162-510). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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



Childrens Nortemp Label (11584 5400 Ballay 4oznortempcc Art)

Childrens Nortemp Label (11584 5400 Ballay 4oznortempcc Art)

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