Skip to Content

← See all Infants Pain Relief Dye-Free brands

Infants Pain Relief Dye-Free by WinCo Foods, LLC

Dosage form: suspension
Ingredients: ACETAMINOPHEN 160mg in 5mL
Labeler: WinCo Foods, LLC
NDC Code: 67091-121

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.

Infants Pain Relief Oral Suspension Dye-Free

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses
  • temporarily reduces fever
  • relieves minor aches and pains due to:
  • the common cold
  • sore throat
  • flu
  • toothache
  • headache

Warnings
  • Liver warning: This product contains acetaminophen. Severe liver damage may occur if the child takes:
  • more than 5 doses in 24 hours, which is maximum daily amount
  • with other drugs containing acetaminophen
  • Sore throat warning: if sore throat is severe, persists for more than 2 days, or 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). Ask a doctor or pharmacist before using with other drugs if you are not sure.
  • 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 dose (see overdose warning)

Stop use and ask a doctor if
  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • These could be signs of a serious condition.

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 for adults as well as for children even if you do not notice any signs or symptoms.

Directions
  • this product does not contain directions or complete warnings for adult dose
  • do not give more than directed (see overdose warning)

  • shake well before use

  • use only enclosed dosing syringe
  • find right dose on chart below
  • remove cap and insert syringe, invert the bottle and draw the liquid to the prescripbed level.
  • dispense liquid slowly into childs mouth towards inner cheek
  • repeat dose every 4 hours if needed
  • do not give more than 5 times in 24 hours
  • replace the cap tightly to maintain child resistance
  • return dispenser to the box after thorough cleaning

Weight (lb) Age (yr) Dose (mL)* 
 under 24 under 2 years ask a doctor
 24-35 lbs 2-3 years 5 mL

* or as directed by a doctor

Other information
  • store between 20-25oC(68-77oF)

Inactive ingredients

citric acid anhydrous, butyl paraben, flavor, glycerin, maltitol, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, propyl paraben, purified water, sucralose, xanthan gum

PDP

*Compare to the active ingredient in Childrens TYLENOL®Suspension

Infants Oral Suspension Pain relief

Acetaminophen 160 mg per 5 mL

Pain reliever-Fever reducer

Alcohol Free

Aspirin & Ibuprofen Free

For Ages 2-3 Years

Dye-Free

Cherry Flavor

2 FL OZ (60 mL) 160 mg per 5 mL

INFANTS PAIN RELIEF DYE-FREE 
acteaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-121
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
BUTYLPARABEN 
GLYCERIN 
MALTITOL 
CELLULOSE, MICROCRYSTALLINE 
CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 50-100 MPA.S AT 1%) 
PROPYLPARABEN 
WATER 
SUCRALOSE 
XANTHAN GUM 
PROPYLENE GLYCOL 
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:67091-121-601 BOTTLE in 1 CARTON
160 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34312/12/2014
Labeler - WinCo Foods, LLC (056098817)

Revised: 11/2014
 
WinCo Foods, LLC

← See all Infants Pain Relief Dye-Free brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide