PAIN RELIEF FEVER REDUCER CHILDREN- acetaminophen suspension 
Ellywell, LLC

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Drug Facts

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

Warnings

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

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:

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 dosage (see overdose warning)

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.

Directions

Weight (lb)Age (year)Dose (mL)*
 under 24under 2ask a doctor
 24-352-35 mL
 36-474-5 7.5 ml
 48-596-810 mL
 60-719-1012.5 mL
 72-951115 mL

*or as directed by a doctor

Other information

Inactive ingredients

disodium EDTA, disodium phosphate heptahydrate, flavors, glycerin, methylparaben, monobasic sodium phosphate monohydrate, purified water, sodium metabisulfite, sorbitol solution, stevia,xanthan gum

Questions or Comments?

Call 312-546-1905 M-F/ 9am-5pm / CST 

Principal Display Panel

ellywell

Children's Pain Reliever & Fever Reducer

acetaminophen 160 mg per 5 mL

oral suspension

**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

Acetaminophen 160 mg

ELLYWELL Children's Pain Reliever & Fever Reducer

PAIN RELIEF FEVER REDUCER  CHILDREN
acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80272-002
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80272-002-041 in 1 BOX09/30/2020
1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01309/30/2020
Labeler - Ellywell, LLC (117625596)

Revised: 10/2023
Document Id: 3391101f-621b-4176-86ab-0908dfc9b2d7
Set id: 92f26bb4-da58-4db4-83bc-aec1ebab2dbf
Version: 5
Effective Time: 20231010
 
Ellywell, LLC