Pain and Fever

Generic name: Acetaminophen

Accudial Pharmaceutical, Inc.

Dosage Form

N/A

Manufacturer

Accudial Pharmaceutical, Inc.

Active ingredient

Acetaminophen160 mg / 5 mL

Important Safety Information

This medication contains important usage instructions, warnings, and side effect information that you should review before use.

Full label on DailyMed PDF Full label (ZIP)

temporarily relieves minor aches and pains due to:

the common cold
flu
headache
sore throat
toothache

temporarily reduces fever

Do not exceed recommended dose.

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.

What it looks like

Photos of the product and/or packaging supplied by the manufacturer.

Package codes (NDC)

45014-131-04

Full prescribing information (for healthcare professionals)

SPL UNCLASSIFIED SECTION

Drug Facts

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.

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.

Other information

each teaspoon contains: sodium 2 mg

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Active ingredient

Important Safety Information

What this medicine is forThe uses this medicine is approved for.

What this medicine is forOver-the-counter use.

How to take itDosage and administration instructions.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 specificall…

Do not use if…Keep out of reach of children.

Ask a doctor before use 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.

Ask a doctor or pharmacist before use if…Ask a doctor or pharmacist before use if the child is taking the blood thinning drug warfarin.

Stop use and talk to a doctor if…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.

Storage and handlingdo 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

Package labelCHILDREN'S ACCUDIAL ROTATING DOSING LABEL ACCURATE DOSING BY WEIGHT CONTAINS Acetaminophen Oral Suspension Pain Reliever,Fever ReducerFor Ages 2 to under 12 Alcohol Free • Aspirin Free • Ibuprofen Free 80 mg per 1/2 teas…