ED APAP description, usages, side effects, indications, overdosage, supplying and lots more!

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ED APAP

EDWARDS PHARMACEUTICALS, INC.

ED APAP


FULL PRESCRIBING INFORMATION: CONTENTS*




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

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.
Weight (lbs.) Age (yrs.) Dose (tsp or mL)
under 24 under 2 Ask a doctor
24-35 2-3 1 tsp or 5 mL
36-47 4-5 1 1/2 tsp or 7.5 mL
48-59 6-8 2 tsp or 10 mL
60-71 9-10 2 1/2 tsp or 12.5 mL
72-95 11 3 tsp or 15 mL

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

ED APAP

ED APAP

ACETAMINOPHEN LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0485-0057
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 160 mg

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
FD&C RED NO. 40
GLYCERIN
polyethylene glycol 400
SODIUM BENZOATE
SODIUM CITRATE
saccharin sodium
sorbitol
water

Product Characteristics

Color
RED

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0485-0057-08 236 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2012-03-07


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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