FeverAll ®

Sun Pharmaceutical Industries, Inc.

Dosage Form

N/A

Manufacturer

Sun Pharmaceutical Industries, Inc.

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:

reduces fever
relieves minor aches and pains due to:
- the common cold
- flu
- headache
- sore throat
- toothache

When using this product do not exceed recommended dose (see overdose warning)

this product does not contain directions or complete warnings for adult use.
do not give more than directed (see overdose warning)
shake well before using
mL = milliliter
find right dose on chart below. If possible, use weight to dose; otherwise, use age.
repeat dose every 4 hours while symptoms last
do not give more than 5 times in 24 hours
do not give more than 5 days unless directed by a doctor.

Weight (lb)	Age (yr)	Dose (mL)
under 24	under 2 years	ask a doctor
24-35 lbs	2-3 years	5 mL
36-47 lbs	4-5 years	7.5 mL
48-59 lbs	6-8 years	10 mL
60-71 lbs	9-10 years	12.5 mL
72-95 lbs	11 years	15 mL

Attention:use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

What it looks like

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

Package codes (NDC)

51672-5319-8

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

SPL UNCLASSIFIED SECTION

Allergy alert:acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

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 case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

SPL UNCLASSIFIED SECTION

Dist. by: Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

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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.this product does not contain directions or complete warnings for adult use. do not give more than directed (see overdose warning) shake well before using mL = milliliter find right dose on chart below. If possible, use…

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 your child istaking the blood thinning drug warfarin

Stop use and talk to a doctor if…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…

Storage and handlingeach 5 mL contains:sodium 3 mg store between 20 to 25°C (68 to 77°F) do not refrigerate Keep carton for full directions for use.

Package labelNEW ORAL SUSPENSION LIQUID NDC 51672-5319-8 CHILDREN'S ages 2-11 years FeverAll ® ACETAMINOPHEN (160 mg/5 mL) Pain Reliever/Fever Reducer Oral Suspension Cherry Flavor DOSING CUP ENCLOSED 4 FL OZ (118 mL)

What it looks like

Package codes (NDC)

SPL UNCLASSIFIED SECTION

Liver warning

SPL UNCLASSIFIED SECTION

Sore throat warning

Overdose warning

SPL UNCLASSIFIED SECTION

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