Pain And Fever
FDA Label NDC 45014-131

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Accudial Pharmaceutical, Inc. for the product Pain And Fever (NDC 45014-131). 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 active ingredient (in each 5 ml = 1 teaspoon), purpose, uses, liver warning, sore throat warning, when using this product, stop use and ask a doctor if, overdose warning, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient (in Each 5 Ml = 1 Teaspoon)

→ Purpose

→ Uses

→ Liver Warning

→ Sore Throat Warning

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ Overdose Warning

→ Directions

→ Other Information

→ Storage & Package Safety

→ Inactive Ingredients

→ Questions?

→ Principal Display Panel - 120 Ml Carton

Active Ingredient (In Each 5 Ml = 1 Teaspoon)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:

the common cold
flu
headache
sore throat
toothache

temporarily reduces fever

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.

When Using This Product

Do not exceed recommended dose.

Stop Use And Ask A Doctor If

Pain gets worse or lasts more than 5 days.
Fever gets worse or lasts more than 3 days.
New symptoms occur.
Redness or swelling is present.

These could be signs of a serious condition.

Overdose Warning

Taking more than the recommended dose (overdose) may cause liver damage. In the 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

shake well before using
if needed, repeat dose every 4 hours
do not use more than 5 times in 24 hours
to find right dose, use rotating bottle label to dose by weight; otherwise, use chart below to dose by age
specifically designed for use with enclosed dosing spoon. Use only enclosed dosing spoon to dose this product. Do not use any other dosing device

Age (yr)	Dose (mL or tsp)
under 2 years	ask a doctor
2-3 years	5 mL or 1 tsp.
4-5 years	7.5 mL or 1½ tsp.
6-8 years	10 mL or 2 tsp.
9-10 years	12.5 mL or 2½ tsp.
11 years	15 mL or 3 tsp.

Other Information

each teaspoon contains: sodium 2 mg

Storage & Package Safety

do not use if inner foil seal is broken or missing
store between 20°-25°C (68°-77°F)
see bottom panel for lot number and expiration date

Inactive Ingredients

artificial flavor, citric acid, corn syrup, FD&C red #40, glycerin, microcrystalline cellulose and carboxymethyl cellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.