Label: PAIN RELIEF FEVER REDUCER CHILDREN- acetaminophen suspension
- NDC Code(s): 80272-002-04
- Packager: Ellywell, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 10, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each 5 mL)
- Purpose
- Uses
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Warnings
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
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
Stop use and ask a doctor if
- new symptoms occur
- redness or swelling is present
- pain gets worse or lasts more than 5 days
- fever gets worse or lasts more than 3 days
These could be signs of a serious condition.<</html>
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 (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.
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Directions
- this product does not contain directions or complete warnings for adult use
- do not take more than directed (see overdose warning)
- shake well before using
- mL= milliliter
- use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device.
- if needed, repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours
- do not give more than 5 days unless directed by a doctor
- find the right dose on chart below. If possible, use weight to dose, use age.
Weight (lb) Age (year) Dose (mL)* under 24 under 2 ask a doctor 24-35 2-3 5 mL 36-47 4-5 7.5 ml 48-59 6-8 10 mL 60-71 9-10 12.5 mL 72-95 11 15 mL *or as directed by a doctor
- Other information
- Inactive ingredients
- Questions or Comments?
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Principal Display Panel
ellywell
Children's Pain Reliever & Fever Reducer
acetaminophen 160 mg per 5 mL
oral suspension
- orange flavor
- sweetener with stevia
- dye-free
- aspirin and ibuprofen free
- alcohol-free
- for ages 2-11 years
**compare to the active ingredient in Children's Tylenol® Oral Suspension
FL OZ (mL)
**This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children's Tylenol® Oral Suspension
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER THE CAP IS BROKEN OR MISSING
Distributed by: Ellywell Naperville, IL
- Product Label
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INGREDIENTS AND APPEARANCE
PAIN RELIEF FEVER REDUCER CHILDREN
acetaminophen suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80272-002 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 SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) METHYLPARABEN (UNII: A2I8C7HI9T) SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) GLYCERIN (UNII: PDC6A3C0OX) STEVIA LEAF (UNII: 6TC6NN0876) SODIUM METABISULFITE (UNII: 4VON5FNS3C) WATER (UNII: 059QF0KO0R) SORBITOL SOLUTION (UNII: 8KW3E207O2) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color Score Shape Size Flavor ORANGE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80272-002-04 1 in 1 BOX 09/30/2020 1 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 09/30/2020 Labeler - Ellywell, LLC (117625596)