Label: ED APAP- acetaminophen liquid
- NDC Code(s): 0485-0057-08
- Packager: EDWARDS PHARMACEUTICALS, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated February 25, 2013
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 5mL = 1 teaspoon)
Acetaminophen 160 mgClose
Pain Reliever / Fever ReducerClose
- reduces fever
- relieves minor aches and pains due to:
- the common cold
- sore throat
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.
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.
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.
- 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.Close
- Inactive ingredients
citric acid, FD&C red #40, flavor, glycerin, PEG 400, sodium benzoate, sodium citrate, sodium saccharin, sorbitol, water.Close
- QUESTIONS? COMMENTS?
- PRINCIPAL DISPLAY PANEL - 236 ml Bottle Label
Contains 160 mg
Acetaminophen in each
8 fl oz (236 ml)
111 Mulberry Street
RIPLEY, MS 38663
- INGREDIENTS AND APPEARANCE
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 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)