ED APAP- acetaminophen liquid 
EDWARDS PHARMACEUTICALS, INC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ED APAP

Drug Facts

Active ingredient (in each 5mL = 1 teaspoon)

Acetaminophen 160 mg

Purpose

Pain Reliever / Fever Reducer

Uses

temporarily:

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

Weight (lbs.)Age (yrs.)Dose (tsp or mL)
under 24under 2Ask a doctor
24-352-31 tsp or 5 mL
36-474-51 1/2 tsp or 7.5 mL
48-596-82 tsp or 10 mL
60-719-102 1/2 tsp or 12.5 mL
72-95113 tsp or 15 mL

Other information

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

Principal Display Panel - 236 ml Bottle Label
ED APAP 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0485-0057
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
FD&C RED NO. 40 
GLYCERIN 
POLYETHYLENE GLYCOL 400 
SODIUM BENZOATE 
SODIUM CITRATE 
SACCHARIN SODIUM 
SORBITOL 
WATER 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0485-0057-08236 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34303/07/2012
Labeler - EDWARDS PHARMACEUTICALS, INC. (195118880)

Revised: 2/2013
Document Id: 9d2f2fbf-0dd3-414f-9747-23dd7e7a7408
Set id: f76d5fff-ebea-40f9-aad3-4064a0c863f0
Version: 1
Effective Time: 20130225
 
EDWARDS PHARMACEUTICALS, INC.