Nortemp
FDA Label NDC 63162-518

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 Nortemp (NDC 63162-518). 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, otc - purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Facts

Active Ingredient: Acetaminophen 80 mg (in each 0.8 mL)

Otc - Purpose

Purpose: Fever reducer/pain reliever

Uses

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.

Otc - Keep Out Of Reach Of Children

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 does not contain directions or complete warnings for adult use ■ do not give more than directed (see overdose warning) ■ find right dose chart, if possible use weight to dose; otherwise, use age ■ use only enclosed dropper designed for use with this product, do not use any other dosing device ■ fill to dose level ■dispense liquid slowly into child's mouth, toward inner cheek ■ may be given alone or mixed with formula, milk, juice etc. ■if needed repeat dose every 4 hours ■do not give more than 5 times in 24 hours ■ Replace dropper tightly to maintain child resistance

Weight (lb)Age (yr)Dose (mL)
Under 24
under 2 years
Ask a Doctor
24-35
2-3 years
1.6 mL (0.8mL +0.8mL)

For accurate dosing follow dosing instructions using the enclosed dropper. Fill dropper to 0.8 mL or prescribed level, and dispense with a single firm squeeze of the dropper bulb

Other information
Store between 20°-25°C (68°-77°F)

Inactive Ingredients

citric acid, FD&C yellow no. 6, cherry flavor, methylparaben, saccharin sodium, sodium benzoate, sodium citrate, propylene glycol and purified water.

Comments

1-800-847-1921

Manufactured for:

BallayPharmaceuticals, Inc.
200 Stillwater St.
Wimberley , TX 78676

Package Label.Principal Display Panel


Carton (Carton)

Carton (Carton)



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