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Drug Facts
Ed Apap Liquid
FDA Label NDC 0485-0057
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Edwards Pharmaceuticals, Inc. for the product Ed Apap (NDC 0485-0057). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient (in each 5ml = 1 teaspoon), purpose, uses, liver warning, sore throat warning, do not use, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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.
Otc - Ask Doctor
Ask a doctor before use if your child has liver disease.
Otc - Ask Doctor/Pharmacist
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.
Otc - Keep Out Of Reach Of Children
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
Principal Display Panel (236 ml Bottle Label)
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