- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 5mL = 1 teaspoon)
- Purpose
- Uses
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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.
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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
- Inactive ingredients
- QUESTIONS? COMMENTS?
- PRINCIPAL DISPLAY PANEL - 236 ml Bottle Label
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INGREDIENTS AND APPEARANCE
ED APAP
acetaminophen liquidProduct 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)