ED APAP

EDWARDS PHARMACEUTICALS, INC.

ED APAP

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each 5mL = 1 teaspoon)
• Purpose
• ED APAP Uses
• Warnings
  • Liver warning
  • Sore throat warning
  • Do not use
  • When using this product
  • Stop use and ask a doctor if
  • Overdose warning
• Directions
• ED APAP Other information
• Inactive ingredients
• QUESTIONS? COMMENTS?
• PRINCIPAL DISPLAY PANEL - 236 ml Bottle Label

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each 5mL = 1 teaspoon)

Acetaminophen 160 mg

Purpose

Pain Reliever / Fever Reducer

ED APAP Uses

temporarily:

• reduces fever
• relieves minor aches and pains due to:
  • the common cold
  • flu
  • headaches
  • sore throat
  • immunizations
  • 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.

Do not use

• with any other drug containing acetaminophen (prescription or non-prescription). 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 dose (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 a serious condition.

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. 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
• shake well before using
• find right dose on chart below. If possible, use weight to dose: otherwise, use age.
• if needed,repeat dose every 4 hours
• do not use more than 5 times in 24 hours
• do not give more than 5 days unless directed by a doctor.

ED APAP Other information

• Store at room temperature 15°-30° C (59°-86° F)
• Protect from freezing
• Protect from Light.
• Each teaspoon (5mL) contains: sodium 7 mg

TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF PRINTED INNER CAP SEAL IS BROKEN OR MISSING.

Inactive ingredients

citric acid, FD&C red #40, flavor, glycerin, PEG 400, sodium benzoate, sodium citrate, sodium saccharin, sorbitol, water.

QUESTIONS? COMMENTS?

Call 1-800-543-9560

PRINCIPAL DISPLAY PANEL - 236 ml Bottle Label

E

NDC 00485-0057-08

ED-APAP
CHILDREN'S

ACETAMINOPHEN
ORAL SOLUTION,
ALCOHOL FREE
CHERRY FLAVORED

Contains 160 mg
Acetaminophen in each
teaspoon (5mL)

8 fl oz (236 ml)

Manufactured for:

EDWARDS
PHARMACEUTICALS, INC.
111 Mulberry Street
RIPLEY, MS 38663