ED APAP- acetaminophen liquid

ED APAP by

Drug Labeling and Warnings

ED APAP by is a Otc medication manufactured, distributed, or labeled by EDWARDS PHARMACEUTICALS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5mL = 1 teaspoon)

Acetaminophen 160 mg

Purpose

Pain Reliever / Fever Reducer

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.

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

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

INGREDIENTS AND APPEARANCE

ED APAP 
acetaminophen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0485-0057
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0485-0057-08	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/07/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	03/07/2012

Labeler - EDWARDS PHARMACEUTICALS, INC. (195118880)