CHILDRENS PAIN RELIEF DYE-FREE- acteaminophen suspension 
WinCo Foods, LLC

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.

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Childrens Pain Relief Oral Suspension Dye-Free

Active ingredients (in each 5 mL teaspoon)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

Warnings

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

 Weight (lb) Age (yr) Dose (mL)
 under 24 lbs under 2 years ask a doctor
 24-35 lbs 2-3 years 5 mL
 36-47 lbs 4-5 years 7.5 mL
 48 - 59 lbs 6-8 years 10 mL
 60 - 71 lbs 9-10 years 12.5 mL
 72 - 95 lbs 11 years 15 mL

Other information

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

Childrens Pain Relief Oral Suspension

ACETAMINOPHEN 160 mg per 5 mL

PAIN RELIEVER-FEVER REDUCER

Alcohol Free

Aspirin & Ibuprofen Free

For Ages 2-11 Years

Dye-Free

Cherry Flavor

4 FL OZ (118 mL) 160 mg per 5 mL

Box

CHILDRENS PAIN RELIEF DYE-FREE 
acteaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-120
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
GLYCERIN (UNII: PDC6A3C0OX)  
MALTITOL (UNII: D65DG142WK)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67091-120-181 in 1 CARTON12/12/2014
1118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34312/12/2014
Labeler - WinCo Foods, LLC (056098817)

Revised: 12/2019
Document Id: b1d63832-b61f-42e5-a257-a831d3ee05b9
Set id: 175c2517-1dff-47c1-aede-6fa1a1ce4f43
Version: 2
Effective Time: 20191209
 
WinCo Foods, LLC